| Primary Device ID | 00197513011934 |
| NIH Device Record Key | 862b6958-3bba-47a0-a5b5-9a1e29448943 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thyroid Shield BAT |
| Version Model Number | R8BATB |
| Company DUNS | 083381202 |
| Company Name | BURLINGTON MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00197513011934 [Primary] |
| IWO | Apron, Protective |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-03 |
| Device Publish Date | 2024-08-26 |
| 00197513011941 | R8BATH (BAT, 0.50MM TS H&L CL W/0.35MM BREAST & AXILLA XENOLITE 800 NLE |
| 00197513011934 | R8BATB (BAT, 0.50MM TS BCKL CL W/0.35MM BREAST & AXILLA XENOLITE 800 NLE |
| 00197513011927 | R8BATM (BAT, 0.50MM TS MAGNET CL W/0.35MM BREAST & AXILLA XENOLITE 800 NLE |
| 00197513011910 | R5BATH (BAT, 0.50MM TS H&L CL W/0.35MM BREAST & AXILLA STRATA 500 |
| 00197513011903 | R5BATB (BAT, 0.50MM TS BCKL CL W/0.35MM BREAST & AXILLA STRATA 500 |
| 00197513011897 | R5BATM (BAT, 0.50MM TS MAGNET CL W/0.35MM BREAST & AXILLA STRATA 500 |