W113
Custom: W113 Side Closure Light Weight Wrap One Piece .35mm Xenolite 600-B Size Three Extra Large Female
6manufacturers in China registered for this device type
100catalogue 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 | 2023-02-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RBW113*M | In distribution | |
| SBW113-2XM | In distribution | |
| RLW113-3XF | In distribution | |
| ULW113-3XF | In distribution | |
| UBW113-2XF | In distribution | |
| U3W113*F | In distribution | |
| RBW113*F | In distribution | |
| SLW113-SM | In distribution | |
| UBW113-2XM | In distribution | |
| SBW113-SM | In distribution | |
| SLW113-XLM | In distribution | |
| UBW113-SF | In distribution | |
| ULW113-XLF | In distribution | |
| SLW113*F | In distribution | |
| RBW113-XSF | In distribution | |
| RBW113-2XM | In distribution | |
| RLW113-PLUS | In distribution | |
| SLW113-2XM | In distribution | |
| RBW113-2XF | In distribution | |
| UBW113-LM | In distribution | |
| SLW113-XLF | In distribution | |
| RBW113-MF | In distribution | |
| SBW113-LM | In distribution | |
| RBW113-XLF | In distribution | |
| S8W113*F | In distribution | |
| SBW113-MF | In distribution | |
| RLW113-2XM | In distribution | |
| RLW113-XLF | In distribution | |
| 00197513006695 | In distribution | |
| ULW113-XLM | In distribution | |
| UBW113-3XM | In distribution | |
| SBW113-XSF | In distribution | |
| RBW113-XSM | In distribution | |
| ULW113-MM | In distribution | |
| SBW113*M | In distribution | |
| ULW113-LM | In distribution | |
| SBW113*F | In distribution | |
| ULW113-2XM | In distribution | |
| ULW113-2XF | In distribution | |
| RLW113-LM | In distribution | |
| ULW113*M | In distribution | |
| SBW113-XLM | In distribution | |
| RLW113-2XF | In distribution | |
| SLW113-2XF | In distribution | |
| SLW113-SF | In distribution | |
| SLW113-LM | In distribution | |
| UBW113-XSM | In distribution | |
| UBW113-SM | In distribution | |
| ULW113-PLUS | In distribution | |
| SBW113-PLUS | In distribution | |
| SBW113-MM | In distribution | |
| RLW113*M | In distribution | |
| SLW113*M | In distribution | |
| SLW113-XSF | In distribution | |
| SLW113-PLUS | In distribution | |
| UBW113-MF | In distribution | |
| SLW113-MF | In distribution | |
| RBW113-XLM | In distribution | |
| RLW113-MM | In distribution | |
| SBW113-3XF | In distribution | |
| RBW113-MM | In distribution | |
| SBW113-XSM | In distribution | |
| ULW113-XSM | In distribution | |
| SLW113-3XM | In distribution | |
| SLW113-3XF | In distribution | |
| SBW113-2XF | In distribution | |
| UBW113-MM | In distribution | |
| ULW113-SF | In distribution | |
| ULW113-SM | In distribution | |
| RBW113-SF | In distribution | |
| SBW113-XLF | In distribution | |
| RLW113-SF | In distribution | |
| RLW113-XSF | In distribution | |
| RBW113-LF | In distribution | |
| SBW113-LF | In distribution | |
| RBW113-3XF | In distribution | |
| RLW113-XLM | In distribution | |
| RLW113*F | In distribution | |
| ULW113-XSF | In distribution | |
| RLW113-3XM | In distribution | |
| SLW113-XSM | In distribution | |
| SBW113-SF | In distribution | |
| ULW113*F | In distribution | |
| RBW113-3XM | In distribution | |
| UBW113-3XF | In distribution | |
| UBW113-XLM | In distribution | |
| UBW113*M | In distribution | |
| RLW113-MF | In distribution | |
| UBW113*F | In distribution | |
| SLW113-LF | In distribution | |
| SBW113-3XM | In distribution | |
| RLW113-XSM | In distribution | |
| SLW113-MM | In distribution | |
| RBW113-SM | In distribution | |
| UBW113-XLF | In distribution | |
| RLW113-SM | In distribution | |
| UBW113-LF | In distribution | |
| RBW113-PLUS | In distribution | |
| UBW113-PLUS | In distribution | |
| RLW113-LF | In distribution |
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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Burlington Medical, LLC | UDI-DI | 2026-02-11 | Class II | Process change control | Potential for attenuation degradation over time, decreasing the lifespan. | 5,198 units |
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.