Thyroid Shield
TS Standard Hook and Loop Tether to Buckle .35mm Burlite Size Medium
6manufacturers in China registered for this device type
1,161catalogue 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 | 2022-09-16 |
| Record revised | 2023-02-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RBTSOBB-MD | In distribution | |
| RBTSOHN-MD | In distribution | |
| ULTSOMT-SM | In distribution | |
| SLTSSBT-SM | In distribution | |
| SBTSBBB-SM | In distribution | |
| RLTSCBN-LG | In distribution | |
| UBTSVBN-SM | In distribution | |
| RBTSOMB-MD | In distribution | |
| UBTSCHR-LG | In distribution | |
| SBTSOHN-LG | In distribution | |
| RBTSSHT-SM | In distribution | |
| SBTSVHR-MD | In distribution | |
| RBTSVBR-LG | In distribution | |
| ULTSCMT-LG | In distribution | |
| SLTSBMN-MD | In distribution | |
| ULTSCMN-MD | In distribution | |
| ULTSVBN-LG | In distribution | |
| RLTSSBS-LG | In distribution | |
| RLTSBMT-MD | In distribution | |
| RBTSBBB-MD | In distribution | |
| ULTSCHB-LG | In distribution | |
| ULTSOMR-MD | In distribution | |
| ULTSOBN-SM | In distribution | |
| UBTSBHN-SM | In distribution | |
| SLTSOMR-LG | In distribution | |
| UBTSBHN-MD | In distribution | |
| RLTSSHR-SM | In distribution | |
| RBTSBBT-SM | In distribution | |
| ULTSCBT-SM | In distribution | |
| RLTSSHT-SM | In distribution | |
| SLTSOMT-LG | In distribution | |
| UBTSVHN-SM | In distribution | |
| SBTSOBR-SM | In distribution | |
| RBTSSHB-SM | In distribution | |
| RBTSOBN-SM | In distribution | |
| RLTSCHS-LG | In distribution | |
| RBTSSBN-MD | In distribution | |
| ULTSBBN-MD | In distribution | |
| ULTSCMR-MD | In distribution | |
| SLTSVHN-LG | In distribution | |
| ULTSOBT-SM | In distribution | |
| SLTSBMR-MD | In distribution | |
| RBTSSBB-LG | In distribution | |
| RBTSBHR-LG | In distribution | |
| SBTSBMB-LG | In distribution | |
| ULTSOBT-LG | In distribution | |
| SLTSSBT-LG | In distribution | |
| SLTSOHN-MD | In distribution | |
| UBTSOHN-MD | In distribution | |
| ULTSCHN-P | In distribution | |
| RBTSCBB-LG | In distribution | |
| SLTSBBB-LG | In distribution | |
| UBTSVHN-LG | In distribution | |
| SBTSSHB-MD | In distribution | |
| RBTSOBT-LG | In distribution | |
| RBTSOBN-MD | In distribution | |
| SBTSOBB-MD | In distribution | |
| UBTSSMT-SM | In distribution | |
| ULTSCHT-LG | In distribution | |
| SLTSSHB-LG | In distribution | |
| RBTSSBT-MD | In distribution | |
| RLTSBHR-MD | In distribution | |
| ULTSCMB-LG | In distribution | |
| RLTSCBN-SM | In distribution | |
| ULTSSHT-MD | In distribution | |
| ULTSOMB-LG | In distribution | |
| SLTSCBT-MD | In distribution | |
| SBTSCHT-SM | In distribution | |
| RBTSVBB-LG | In distribution | |
| RBTSSMR-SM | In distribution | |
| RLTSCMT-MD | In distribution | |
| SLTSCBS-MD | In distribution | |
| ULTSSHS-LG | In distribution | |
| SBTSVHN-MD | In distribution | |
| UBTSOMN-LG | In distribution | |
| RLTSCHS-SM | In distribution | |
| RBTSBBB-LG | In distribution | |
| RBTSVBB-SM | In distribution | |
| RBTSCHN-MD | In distribution | |
| SLTSCMN-MD | In distribution | |
| ULTSVBT-MD | In distribution | |
| RLTSVHR-LG | In distribution | |
| UBTSBBR-SM | In distribution | |
| UBTSCMT-SM | In distribution | |
| RLTSSHT-LG | In distribution | |
| UBTSSHR-MD | In distribution | |
| ULTSSBN-SM | In distribution | |
| RBTSOHT-LG | In distribution | |
| SLTSCHR-LG | In distribution | |
| UBTSCBB-SM | In distribution | |
| RBTSSBR-MD | In distribution | |
| SBTSCBR-SM | In distribution | |
| RBTSBHN-SM | In distribution | |
| UBTSBHT-LG | In distribution | |
| SLTSVHT-SM | In distribution | |
| RLTSCMB-MD | In distribution | |
| UBTSCHN-LG | In distribution | |
| ULTSCMB-MD | In distribution | |
| ULTSVMB-SM | In distribution | |
| RBTSCMR-LG | In distribution | |
| SBTSVBR-SM | In distribution | |
| RBTSCMT-MD | In distribution | |
| SBTSVBR-MD | In distribution | |
| SLTSOMT-MD | In distribution | |
| RLTSOHR-MD | In distribution | |
| RLTSSMB-LG | In distribution | |
| ULTSBMT-MD | In distribution | |
| UBTSVHT-SM | In distribution | |
| RBTSBMN-MD | In distribution | |
| SBTSVMN-LG | In distribution | |
| ULTSSMN-LG | In distribution | |
| RLTSBHN-MD | In distribution | |
| SLTSSBB-LG | In distribution | |
| RLTSBMB-SM | In distribution | |
| UBTSBBT-MD | In distribution | |
| RBTSVMT-LG | In distribution | |
| UBTSCHT-SM | In distribution | |
| ULTSSBR-SM | In distribution | |
| SBTSVMB-MD | In distribution | |
| ULTSCHN-LG | In distribution | |
| SBTSSHB-LG | In distribution | |
| ULTSBBR-SM | In distribution | |
| UBTSOHB-LG | In distribution | |
| RBTSCMT-LG | In distribution | |
| UBTSCHB-MD | In distribution | |
| UBTSCMT-LG | In distribution | |
| RBTSCMN-LG | In distribution | |
| SBTSSBR-MD | In distribution | |
| ULTSOBR-LG | In distribution | |
| RLTSSHB-LG | In distribution | |
| ULTSSMT-SM | In distribution | |
| SBTSSHS-SM | In distribution | |
| SLTSOHR-LG | In distribution | |
| RBTSCMB-MD | In distribution | |
| RLTSVBR-SM | In distribution | |
| RLTSSBT-SM | In distribution | |
| SBTSBBT-LG | In distribution | |
| RLTSSHN-SM | In distribution | |
| SLTSCHT-P | In distribution | |
| RLTSSHN-MD | In distribution | |
| SLTSBBN-LG | In distribution | |
| RLTSSBB-LG | In distribution | |
| RBTSBHR-MD | In distribution | |
| UBTSCMN-MD | In distribution | |
| SBTSSBS-MD | In distribution | |
| RLTSVHB-SM | In distribution | |
| SLTSBBT-MD | In distribution | |
| UBTSBHN-LG | In distribution | |
| SLTSCHB-MD | In distribution | |
| ULTSVBN-MD | In distribution | |
| RBTSVBT-MD | In distribution | |
| ULTSVHN-MD | In distribution | |
| UBTSVMN-MD | In distribution | |
| SLTSSBB-SM | In distribution | |
| ULTSBMR-MD | In distribution | |
| ULTSCMN-P | In distribution | |
| RLTSVHT-LG | In distribution | |
| SLTSBMB-SM | In distribution | |
| ULTSOBN-MD | In distribution | |
| SBTSBHR-SM | In distribution | |
| RBTSVBN-SM | In distribution | |
| SLTSBHN-LG | In distribution | |
| RLTSOBB-MD | In distribution | |
| SLTSCMR-MD | In distribution | |
| SLTSBHB-SM | In distribution | |
| SLTSOMR-MD | In distribution | |
| RBTSVHN-SM | In distribution | |
| SLTSVHN-MD | In distribution | |
| UBTSBBN-SM | In distribution | |
| UBTSVHB-LG | In distribution | |
| RBTSSHS-SM | In distribution | |
| ULTSOMN-LG | In distribution | |
| UBTSOBT-MD | In distribution | |
| SLTSOMN-LG | In distribution | |
| SLTSSMN-LG | In distribution | |
| RBTSCHR-MD | In distribution | |
| ULTSBHN-LG | In distribution | |
| SLTSBMR-SM | In distribution | |
| SLTSBMN-LG | In distribution | |
| SLTSCBS-SM | In distribution | |
| RBTSCBN-MD | In distribution | |
| RLTSSMR-MD | In distribution | |
| UBTSBHR-LG | In distribution | |
| UBTSSHN-LG | In distribution | |
| ULTSCBN-LG | In distribution | |
| ULTSVHB-LG | In distribution | |
| RLTSOBB-SM | In distribution | |
| RBTSSBT-SM | In distribution | |
| RLTSSMR-LG | In distribution | |
| SBTSOHN-SM | In distribution | |
| SLTSSHT-MD | In distribution | |
| SLTSBHR-MD | In distribution | |
| SLTSSHN-LG | In distribution | |
| RLTSBMR-MD | In distribution | |
| RLTSSBT-MD | In distribution | |
| SLTSCHS-MD | In distribution | |
| SLTSSHT-LG | In distribution | |
| UBTSOMN-SM | In distribution | |
| RBTSVBR-SM | In distribution | |
| RLTSBMR-LG | In distribution | |
| SBTSOBR-LG | In distribution | |
| SBTSOMT-SM | In distribution | |
| UBTSSHR-LG | In distribution | |
| SBTSSBS-LG | In distribution | |
| SLTSSHR-MD | In distribution | |
| RBTSCHT-MD | In distribution | |
| SBTSSBN-MD | In distribution | |
| SBTSBHB-SM | In distribution | |
| SLTSBHR-LG | In distribution | |
| SBTSOBN-MD | In distribution | |
| ULTSSBB-LG | In distribution | |
| RLTSBBR-MD | In distribution | |
| SBTSVBT-SM | In distribution | |
| RBTSVBN-LG | In distribution | |
| SLTSSBT-MD | In distribution | |
| RLTSVMN-LG | In distribution | |
| UBTSSBB-LG | In distribution | |
| SLTSCMB-SM | In distribution | |
| SBTSVHR-SM | In distribution | |
| SLTSCBN-MD | In distribution | |
| ULTSVMB-MD | In distribution | |
| SLTSOHN-SM | In distribution | |
| ULTSCMR-LG | In distribution | |
| SLTSCMT-MD | In distribution | |
| SLTSSMN-MD | In distribution | |
| UBTSOMT-LG | In distribution | |
| ULTSSHT-SM | In distribution | |
| SLTSSHS-MD | In distribution | |
| RLTSBBB-LG | In distribution | |
| SLTSOHB-SM | In distribution | |
| RBTSVMR-LG | In distribution | |
| RLTSOMN-SM | In distribution | |
| UBTSCHS-SM | In distribution | |
| ULTSBHB-LG | In distribution | |
| UBTSCMR-LG | In distribution | |
| UBTSCMB-SM | In distribution | |
| ULTSCBB-LG | In distribution | |
| RLTSBMN-MD | In distribution | |
| RLTSOMN-LG | In distribution | |
| ULTSCBB-MD | In distribution | |
| ULTSVBB-SM | In distribution | |
| SLTSSMN-SM | In distribution | |
| SBTSCMT-SM | In distribution | |
| ULTSCMT-SM | In distribution | |
| ULTSVHN-SM | In distribution | |
| RLTSBHT-SM | In distribution | |
| UBTSBBB-MD | In distribution | |
| ULTSVBR-SM | In distribution | |
| SLTSVMB-LG | In distribution | |
| RLTSOHB-LG | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.