F111
Custom F111: 1 Piece Wrap Around with Wide Stretch Belt .35mm Regular Lead Size Female Three Extra Large, SLF111-3XF
6manufacturers in China registered for this device type
322catalogue numbers in this listing
24recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Ekong Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Burlington Medical, LLC, United States |
|---|---|
| FDA product code | EAJ |
| Device type | Apron, Leaded |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCCF111-XSF | In distribution | |
| UBF1113XLF | 3XL Female | In distribution |
| SLF111*M | Tailored | In distribution |
| RCCF111-3XF | In distribution | |
| UBF111C | Male Large | In distribution |
| RTLF111-3XF | In distribution | |
| RBF111-LF | In distribution | |
| ULF111*M | Tailored | In distribution |
| ULF1117XLF | 7XL Female | In distribution |
| ULF1115XLF | In distribution | |
| UBF1113XLM | 3XL Male | In distribution |
| UBF1118XLM | 8XL Male | In distribution |
| RLF111B | Male Medium | In distribution |
| RLF111G | Female Large Plus | In distribution |
| SCCF111-XLM | In distribution | |
| UBF111-PLUS | In distribution | |
| RBF111-2XM | Male XL | In distribution |
| SBF111C | Male Large | In distribution |
| ULF1114XLM | 4XL Male | In distribution |
| RTLF111-4XM | In distribution | |
| SCCF111-4XF | In distribution | |
| RLF111XXLM | 2XL Male | In distribution |
| SLF1117XLM | 7XL Male | In distribution |
| SLF1117XLF | 7XL Female | In distribution |
| UBF111XXLM | 2XL Male | In distribution |
| UBF111XLF | Female XL | In distribution |
| RBF1118XLM | 8XL Male | In distribution |
| RLF1113XLM | 3XL Male | In distribution |
| ULF111A | Male Small | In distribution |
| UBF111-XXSF | In distribution | |
| RTLF111-7XF | Male XL | In distribution |
| RCCF111-6XF | In distribution | |
| SCCF111-5XM | In distribution | |
| SLF111F | Female Large | In distribution |
| SBF111-MF | In distribution | |
| UBF111F | Female Large | In distribution |
| RCCF111-LM | In distribution | |
| SBF1113XLM | 3XL Male | In distribution |
| UBF111D | Female Small | In distribution |
| SBF111XLF | Female XL | In distribution |
| SLF111XXLM | 2XL male | In distribution |
| ULF111D | Female Small | In distribution |
| RTLF111-6XM | Male XL | In distribution |
| RLF1115XLF | 5XL Female | In distribution |
| RCCF111-SF | In distribution | |
| UBF1115XLF | 5XL Female | In distribution |
| ULF111-XLF | In distribution | |
| RBF1118XLF | 8XL Female | In distribution |
| RLF111-SF | In distribution | |
| RCCF111-8XM | In distribution | |
| RBF111-MM | In distribution | |
| SBF111*F | Tailored | In distribution |
| UBF111A | Male Small | In distribution |
| SLF111D | Female Small | In distribution |
| RBF111-3XF | Male XL | In distribution |
| RTLF111-7XM | Male XL | In distribution |
| RBF111D | Female Small | In distribution |
| RCCF111-SM | In distribution | |
| RBF1113XLM | 3XL Male | In distribution |
| SCCF111-8XF | In distribution | |
| SBF111A | Male Small | In distribution |
| RCCF111-XXF | In distribution | |
| RLF111-3XF | In distribution | |
| ULF111C | Male Large | In distribution |
| ULF111-3XM | In distribution | |
| SLF111-2XF | In distribution | |
| RLF111D | Female Small | In distribution |
| RBF111-LM | In distribution | |
| SLF111-3XF | In distribution | |
| UBF111-LM | In distribution | |
| RTLF111-XSM | Male XL | In distribution |
| RLF111*M | Tailored | In distribution |
| RTLF111-MF | Male XL | In distribution |
| RLF111*F | Tailored | In distribution |
| SLF111A | Male Small | In distribution |
| ULF111-MF | In distribution | |
| RCCF111-PF | In distribution | |
| SLF111-2XM | In distribution | |
| SCCF111-SM | In distribution | |
| RLF111E | Female Medium | In distribution |
| SBF1117XLM | 7XL Male | In distribution |
| UBF111*F | Tailored | In distribution |
| RLF111-LF | In distribution | |
| SCCF111-8XM | In distribution | |
| ULF111XSF | XS Female | In distribution |
| RCCF111-XLF | In distribution | |
| SBF1115XLM | 5XL Male | In distribution |
| RCCF111-6XM | In distribution | |
| SCCF111-7XM | In distribution | |
| RTLF111-6XF | Male XL | In distribution |
| SLF111-LM | In distribution | |
| UBF111-SM | In distribution | |
| UBF1114XLM | 4XL Male | In distribution |
| RLF111-XXSF | In distribution | |
| SCCF111-LF | In distribution | |
| SCCF111-XXF | In distribution | |
| SCCF111-XSM | In distribution | |
| SCCF111-7XF | In distribution | |
| RCCF111-MF | In distribution | |
| RLF111-2XM | In distribution | |
| ULF111-2XF | In distribution | |
| UBF1114XLF | 4Xl Female | In distribution |
| SBF111XSF | XS Female | In distribution |
| RLF1116XLF | 6XL Female | In distribution |
| SBF1116XLM | 6XL Male | In distribution |
| SBF111-XXSF | In distribution | |
| RCCF111-4XM | In distribution | |
| RBF1116XLM | 6XL Male | In distribution |
| SBF1118XLM | 8XL Male | In distribution |
| SLF1113XLM | 3XL Male | In distribution |
| RLF1118XLF | 8XL Female | In distribution |
| RCCF111-4XF | In distribution | |
| RCCF111-XLM | In distribution | |
| SBF111D | Female Small | In distribution |
| SLF1114XLM | 4XL Male | In distribution |
| ULF111F | Female Large | In distribution |
| RBF111-SM | In distribution | |
| UBF1117XLF | 7XL Female | In distribution |
| SBF1118XLF | 8XL Female | In distribution |
| UBF111-3XF | Male XL | In distribution |
| SBF111F | Female Large | In distribution |
| RLF1115XLM | 5XL Male | In distribution |
| SLF1116XLM | 6XL Male | In distribution |
| SLF111-XSM | In distribution | |
| RBF111-XXSF | In distribution | |
| RBF111XSF | XS Female | In distribution |
| UBF111-2XF | Male XL | In distribution |
| SBF111XLM | Male XL | In distribution |
| RLF111-2XF | In distribution | |
| RLF1114XLM | 4XL Male | In distribution |
| SCCF111-4XM | In distribution | |
| SLF1115XLF | 5XL Female | In distribution |
| SLF111-LF | In distribution | |
| RTLF111-XXF | Male XL | In distribution |
| SLF1116XLF | 6XL Female | In distribution |
| RLF111-MM | In distribution | |
| SBF111-2XF | Male XL | In distribution |
| SCCF111-6XM | In distribution | |
| SBF111-LF | In distribution | |
| RTLF111-XXM | Male XL | In distribution |
| ULF111-XXSF | In distribution | |
| SLF111-PLUS | In distribution | |
| RLF1117XLF | 7XL Female | In distribution |
| RCCF111-7XM | In distribution | |
| UBF1116XLM | 6XL Male | In distribution |
| UBF1117XLM | 7XL Male | In distribution |
| RCCF111-XSF | In distribution | |
| UBF111-LF | In distribution | |
| RLF111-MF | In distribution | |
| RLF1117XLM | 7XL Male | In distribution |
| SLF111-MM | In distribution | |
| SBF111-2XM | Male XL | In distribution |
| RTLF111-8XF | Male XL | In distribution |
| RTLF111-XLF | Male XL | In distribution |
| RCCF111-MM | In distribution | |
| SBF1115XLF | 5XL Female | In distribution |
| RBF111G | Female Large Plus | In distribution |
| RCCF111-5XM | In distribution | |
| UBF111XLM | Male XL | In distribution |
| SBF1117XLF | 7XL Female | In distribution |
| UBF1116XLF | 6XL Female | In distribution |
| RLF111-SM | In distribution | |
| SLF111E | Female Medium | In distribution |
| RTLF111-LF | Male XL | In distribution |
| RBF1115XLF | 5XL Female | In distribution |
| SLF111C | Male Large | In distribution |
| RTLF111-4XF | In distribution | |
| SBF1114XLM | 4XL Male | In distribution |
| RLF111XLF | Female XL | In distribution |
| SBF111-SM | In distribution | |
| ULF1115XLM | 5XL Male | In distribution |
| RTLF111-SF | Male XL | In distribution |
| RLF1116XLM | 6XL Male | In distribution |
| UBF111-2XM | Male XL | In distribution |
| RTLF111-3XM | In distribution | |
| UBF1115XLM | 5XL Male | In distribution |
| SCCF111-XLF | In distribution | |
| UBF111G | Female Large Plus | In distribution |
| SBF1113XLF | 3XL Female | In distribution |
| SLF1113XLF | 3XL Female | In distribution |
| SLF1114XLF | 4XL Female | In distribution |
| ULF111E | Female Medium | In distribution |
| UBF1118XLF | 8XL Female | In distribution |
| ULF111-SF | In distribution | |
| SBF111-PLUS | In distribution | |
| RTLF111-PF | Male XL | In distribution |
| SLF111-MF | In distribution | |
| RLF111-LM | In distribution | |
| SLF111XSF | XS Female | In distribution |
| ULF111-SM | In distribution | |
| UBF111-SF | In distribution | |
| STLF111-3XF | In distribution | |
| RBF111B | Male Medium | In distribution |
| RBF1116XLF | 6Xl Female | In distribution |
| SCCF111-5XF | In distribution | |
| RBF111C | Male Large | In distribution |
| RBF111F | Female Large | In distribution |
| RLF111C | Male Large | In distribution |
| ULF111-XLM | In distribution | |
| RLF1114XLF | 4XL Female | In distribution |
| SLF111-SF | In distribution | |
| RTLF111-5XM | Male XL | In distribution |
| ULF111XXLM | 2XL Male | In distribution |
| RCCF111-5XF | In distribution | |
| ULF1117XLM | 7XL Male | In distribution |
| SBF111-3XM | Male XL | In distribution |
| SLF111XLM | Male XL | In distribution |
| ULF111-3XF | In distribution | |
| RTLF111-MM | Male XL | In distribution |
| SCCF111-XXM | In distribution | |
| UBF111-3XM | Male XL | In distribution |
| SBF1114XLF | 4XL Female | In distribution |
| RLF1118XLM | 8XL Male | In distribution |
| ULF111-PLUS | In distribution | |
| ULF111G | Female Large Plus | In distribution |
| RBF1117XLF | 7XL Female | In distribution |
| RBF111-MF | In distribution | |
| RLF111-XSM | In distribution | |
| RBF111-3XM | Male XL | In distribution |
| RBF111-PLUS | In distribution | |
| ULF111XLF | Female XL | In distribution |
| SCCF111-6XF | In distribution | |
| ULF1116XLM | 6XL Male | In distribution |
| RBF111E | Female Medium | In distribution |
| SLF111-XXSF | In distribution | |
| RLF1113XLF | 3XL Female | In distribution |
| ULF111-XSF | In distribution | |
| SCCF111-MF | In distribution | |
| ULF1113XLM | 3XL Male | In distribution |
| RTLF111-XLM | Male XL | In distribution |
| SBF111-LM | In distribution | |
| SBF111-MM | In distribution | |
| SLF111XSM | XS Male | In distribution |
| RCCF111-3XM | In distribution | |
| RBF111-2XF | Male XL | In distribution |
| SBF111-SF | In distribution | |
| ULF111*F | Tailored | In distribution |
| RTLF111-8XM | Male XL | In distribution |
| ULF1118XLM | 8XL Male | In distribution |
| ULF1118XLF | 8XL Female | In distribution |
| UBF111XSF | XS Female | In distribution |
| SLF111XLF | Female XL | In distribution |
| SLF111-XLM | In distribution | |
| RBF111A | Male Small | In distribution |
| UBF111XXLF | 2XL Female | In distribution |
| SLF1118XLF | 8XL Female | In distribution |
| UBF111B | Male Medium | In distribution |
| RBF1115XLM | 5XL Male | In distribution |
| UBF111E | Female Medium | In distribution |
| ULF111-2XM | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thyroid Shield | Burlington Medical, LLC | 1,161 |
| Wolf X-Ray | Flow X-Ray Corp. | 909 |
| ComfortLite | Aadco Medical, Inc. | 538 |
| Palmero Healthcare, LLC | Palmero Healthcare LLC | 402 |
| Euro | Burlington Medical, LLC | 390 |
| Rayshield | Aadco Medical, Inc. | 380 |
| 601 | Burlington Medical, LLC | 352 |
| F17 | Burlington Medical, LLC | 345 |
| Techno-Aide | Techno-Aide, Inc. | 327 |
| Skirt | Burlington Medical, LLC | 312 |
| A10 | Burlington Medical, LLC | 286 |
| F112 | Burlington Medical, LLC | 283 |
Showing 12 of 118. All products under Apron, Leaded
Recalls
24 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 129 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 210 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 332 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 22 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 37 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 49 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 7 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 48 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 1 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2190 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 6 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 51 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 807 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 2 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 3 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 310 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 104 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 39 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 23 | 2023-04-28 |
| 2019-06-07 | Class II | Under Investigation by firm | The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many differ | 9 | 2023-04-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.