Primary Device ID | 00197513011941 |
NIH Device Record Key | 8b146d58-75ce-42c8-a9c2-6a001d65ccca |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Thyroid Shield BAT |
Version Model Number | R8BATH |
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 | 00197513011941 [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 |