F112
Custom F112: Full Overlap Front/Back Apron with Velcro Closure .35mm Regular Lead Size Female Three Extra Large, SLF112-3XF
6manufacturers in China registered for this device type
283catalogue 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 | 2020-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RBF112B | Male Medium | In distribution |
| SCCF112-SF | In distribution | |
| RBF112-LM | In distribution | |
| RBF1126XLM | 6XL Male | In distribution |
| SBF112F | Female Large | In distribution |
| RCCF112-8XM | In distribution | |
| UBF112*M | In distribution | |
| RLF112-XLM | In distribution | |
| UBF112-3XM | In distribution | |
| RBF112-LF | In distribution | |
| SCCF112-7XF | In distribution | |
| SCCF112-4XF | In distribution | |
| SLF112B | Male Medium | In distribution |
| SLF112-XSM | In distribution | |
| STLF111-3XM | In distribution | |
| SCCF112-XSF | In distribution | |
| RCCF112-PF | In distribution | |
| RTLF112-SM | In distribution | |
| STLF112-6XM | In distribution | |
| SLF112XSM | XS Male | In distribution |
| RLF1124XLM | 4XL Male | In distribution |
| RCCF112-SF | In distribution | |
| RCCF112-3XF | In distribution | |
| SBF112A | Male Small | In distribution |
| RLF1125XLF | 5XL Female | In distribution |
| SCCF112-4XM | In distribution | |
| RTLF112-XXF | In distribution | |
| RBF1124XLF | 4XL Female | In distribution |
| SBF112E | Female Medium | In distribution |
| RBF112-3XM | Male XL | In distribution |
| SCCF112-XSM | In distribution | |
| RLF112XLF | Female XL | In distribution |
| STLF112-SF | In distribution | |
| RLF112B | Male Medium | In distribution |
| RLF112-3XF | In distribution | |
| SLF1128XLM | 8XL Male | In distribution |
| SLF112-XLM | In distribution | |
| SBF1128XLF | 8XL Female | In distribution |
| RCCF112-6XM | In distribution | |
| SBF112D | Female Small | In distribution |
| SLF112XSF | XS Female | In distribution |
| SLF112E | Female Medium | In distribution |
| STLF112-MM | In distribution | |
| SLF112-3XF | In distribution | |
| RLF112-XXSF | In distribution | |
| SCCF112-3XF | In distribution | |
| RCCF112-LM | In distribution | |
| STLF112-XLM | In distribution | |
| SLF112-MF | In distribution | |
| RTLF112-7XM | In distribution | |
| RTLF112-8XF | In distribution | |
| SLF112-XSF | In distribution | |
| RTLF112-XXM | In distribution | |
| RBF112-SM | In distribution | |
| RCCF112-8XF | In distribution | |
| SBF112C | Male Large | In distribution |
| RBF1123XLF | 3XL Female | In distribution |
| STLF112-8XM | In distribution | |
| SBF112-XXSF | In distribution | |
| SLF112A | Male Small | In distribution |
| RLF112XXLM | 2XL Male | In distribution |
| RBF1128XLM | 8XL Male | In distribution |
| SLF112*M | Tailored | In distribution |
| STLF112-5XM | In distribution | |
| RLF1126XLM | 6XL Male | In distribution |
| SBF1124XLF | 4XL Female | In distribution |
| RCCF112-SM | In distribution | |
| RCCF112-7XF | In distribution | |
| UBF112-2XM | In distribution | |
| RTLF112-SF | In distribution | |
| RLF112-MM | In distribution | |
| RLF112-3XM | In distribution | |
| SLF112-SF | In distribution | |
| RTLF112-5XM | In distribution | |
| RLF112XXLF | 2XL Female | In distribution |
| STLF112-XSM | In distribution | |
| STLF112-3XM | In distribution | |
| RBF112-3XF | Male XL | In distribution |
| RCCF112-XXF | In distribution | |
| RTLF112-XLF | In distribution | |
| SBF112XLF | Female XL | In distribution |
| SCCF112-XLF | In distribution | |
| RBF112XSM | XS Male | In distribution |
| RLF1127XLF | 7XL Female | In distribution |
| UBF112-XSM | Male XL | In distribution |
| SLF112XXLM | 2XL Male | In distribution |
| SBF112XLM | Male XL | In distribution |
| RCCF112-LF | In distribution | |
| RTLF112-5XF | In distribution | |
| RLF112-XLF | In distribution | |
| SBF1127XLF | 7XL Female | In distribution |
| RTLF112-6XF | In distribution | |
| RBF112XXLM | 2XL Male | In distribution |
| SBF1126XLM | In distribution | |
| RBF112-XXSF | In distribution | |
| RBF1124XLM | 4XL Male | In distribution |
| SBF112-SF | In distribution | |
| RLF112-XSM | In distribution | |
| SLF112-XLF | In distribution | |
| STLF112-4XM | In distribution | |
| RBF112XSF | XS Female | In distribution |
| RLF112A | Male Small | In distribution |
| STLF112-3XF | In distribution | |
| SLF112-PLUS | In distribution | |
| SLF1127XLM | 7XL Male | In distribution |
| RLF112E | Female Medium | In distribution |
| SLF112G | Female Large Plus | In distribution |
| RLF112D | Female Small | In distribution |
| SBF1127XLM | 7XL Male | In distribution |
| RBF1123XLM | 3XL Male | In distribution |
| RLF1128XLF | 8XL Female | In distribution |
| SLF112XXLF | 2XL Female | In distribution |
| RLF112C | Male Large | In distribution |
| RLF1126XLF | 6XL Female | In distribution |
| RCCF112-5XF | In distribution | |
| SBF112-PLUS | In distribution | |
| SBF112-3XM | Male XL | In distribution |
| RLF112-XSF | In distribution | |
| RTLF112-MM | In distribution | |
| UBF112-2XF | In distribution | |
| SCCF112-5XF | In distribution | |
| STLF112-XXF | In distribution | |
| SCCF112-LF | In distribution | |
| UBF112-XLM | In distribution | |
| SBF1128XLM | 8XL Male | In distribution |
| SBF112-LF | In distribution | |
| RTLF112-XSM | In distribution | |
| RCCF112-4XM | In distribution | |
| RCCF112-XSF | In distribution | |
| RTLF112-LM | In distribution | |
| SBF112G | Female Large Plus | In distribution |
| UBF112-PLUS | In distribution | |
| SLF1123XLF | 3XL Female | In distribution |
| RLF1123XLM | 3XL Male | In distribution |
| RBF1125XLM | 5XL Male | In distribution |
| SBF112*M | Tailored | In distribution |
| RLF112XSF | XS Female | In distribution |
| RLF112*F | Tailored | In distribution |
| SCCF112-6XM | In distribution | |
| UBF112-MM | In distribution | |
| RCCF112-7XM | In distribution | |
| RBF1128XLF | 8XL Female | In distribution |
| RBF112A | Male Small | In distribution |
| RLF112-SF | In distribution | |
| SCCF112-8XM | In distribution | |
| SLF112F | Female Lar | In distribution |
| RBF112-SF | In distribution | |
| UBF112-XSF | Male XL | In distribution |
| SLF1127XLF | 7XL Female | In distribution |
| SCCF112-6XF | In distribution | |
| RBF112XLF | Female XL | In distribution |
| RTLF112-MF | In distribution | |
| RBF112E | Female Medium | In distribution |
| RLF1128XLM | 8XL Male | In distribution |
| RLF112G | Female Large Plus | In distribution |
| RTLF112-XSF | In distribution | |
| RCCF112-XLF | In distribution | |
| RCCF112-6XF | In distribution | |
| RCCF112-XLM | In distribution | |
| UBF112-SM | In distribution | |
| UBF112-LF | In distribution | |
| SLF112XLF | Female XL | In distribution |
| STLF112-XSF | In distribution | |
| UBF112-LM | In distribution | |
| RBF1127XLM | 7XL Male | In distribution |
| SCCF112-XXM | In distribution | |
| SCCF112-SM | In distribution | |
| SLF112-XXSF | In distribution | |
| RBF112-2XF | Male XL | In distribution |
| RBF112C | Male Large | In distribution |
| SCCF112-LM | In distribution | |
| SBF1126XLF | 6XL Female | In distribution |
| RLF112-LM | In distribution | |
| RBF112-MM | In distribution | |
| SLF112-3XM | In distribution | |
| SLF112*F | Tailored | In distribution |
| SBF112-LM | In distribution | |
| RBF112F | Female Large | In distribution |
| SBF1123XLM | 3XL Male | In distribution |
| RTLF112-8XM | In distribution | |
| SLF1125XLF | 5XL Female | In distribution |
| SLF1126XLM | 6XL Male | In distribution |
| SLF112-2XF | In distribution | |
| SBF1125XLM | 5XL Male | In distribution |
| RLF112*M | Tailored | In distribution |
| RBF112-MF | In distribution | |
| RCCF112-MF | In distribution | |
| STLF112-7XM | In distribution | |
| RCCF112-3XM | In distribution | |
| SBF112XXLF | 2XL Female | In distribution |
| RLF1125XLM | 5XL Male | In distribution |
| STLF112-MF | In distribution | |
| RCCF112-5XM | In distribution | |
| SCCF112-XXF | In distribution | |
| SBF1125XLF | 5XL Female | In distribution |
| RLF112-2XF | In distribution | |
| STLF112-8XF | In distribution | |
| RBF112D | Female Small | In distribution |
| RLF1127XLM | 7XL Male | In distribution |
| RLF1123XLF | 3XL Female | In distribution |
| RBF112-PLUS | In distribution | |
| SLF112-LM | In distribution | |
| SLF112-MM | In distribution | |
| SBF112-MM | In distribution | |
| STLF112-5XF | In distribution | |
| RLF112-2XM | In distribution | |
| UBF112-XLF | In distribution | |
| RTLF112-3XM | In distribution | |
| SBF112-2XF | Male XL | In distribution |
| STLF112-PF | In distribution | |
| SLF112D | Female Small | In distribution |
| RLF112-PLUS | In distribution | |
| UBF112-XXSF | In distribution | |
| RCCF112-MM | In distribution | |
| SLF112-SM | In distribution | |
| SBF112-3XF | Male XL | In distribution |
| SLF1126XLF | 6XL Female | In distribution |
| UBF112-SF | In distribution | |
| RCCF112-XSM | In distribution | |
| RCCF112-4XF | In distribution | |
| SBF112XSF | XS Female | In distribution |
| SLF112XLM | Male XL | In distribution |
| RBF112G | Female Large Plus | In distribution |
| RBF112XLM | Male XL | In distribution |
| RTLF112-4XM | In distribution | |
| RBF112*M | Tailored | In distribution |
| STLF112-6XF | In distribution | |
| RTLF112-6XM | In distribution | |
| SCCF112-MF | In distribution | |
| RTLF112-7XF | In distribution | |
| STLF112-SM | In distribution | |
| STLF112-LM | In distribution | |
| SLF112C | Male Large | In distribution |
| RBF112-2XM | Male XL | In distribution |
| SCCF112-MM | In distribution | |
| SLF112-2XM | In distribution | |
| UBF112*F | In distribution | |
| RBF112*F | Tailored | In distribution |
| SBF1123XLF | 3XL Female | In distribution |
| STLF112-4XF | In distribution | |
| STLF112-XLF | In distribution | |
| SLF112-LF | In distribution | |
| SBF112XXLM | 2XL Male | In distribution |
| RTLF112-XLM | In distribution | |
| SCCF112-XLM | In distribution | |
| SBF112*F | Tailored | In distribution |
| RTLF112-4XF | In distribution | |
| RLF112F | Female Large | In distribution |
| SBF112B | Male Medium | In distribution |
| SBF112-2XM | Male XL | In distribution |
Showing 250 of 283 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 |
| F111 | Burlington Medical, LLC | 322 |
| Skirt | Burlington Medical, LLC | 312 |
| A10 | Burlington Medical, LLC | 286 |
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.