Primary Device ID | 08800039006682 |
NIH Device Record Key | 2f1c88a8-cd57-457e-a01a-dc9819926f02 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TBS PTFE membrane |
Version Model Number | TBSRGN08 |
Company DUNS | 687429456 |
Company Name | PURGO BIOLOGICS Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800039006682 [Primary] |
NPK | Barrier, Synthetic, Intraoral |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-01 |
Device Publish Date | 2025-07-24 |
08800039006651 - TBS PTFE Suture | 2025-08-01 |
08800039006668 - TBS PTFE Suture | 2025-08-01 |
08800039006675 - TBS PTFE Suture | 2025-08-01 |
08800039006682 - TBS PTFE membrane | 2025-08-01 |
08800039006682 - TBS PTFE membrane | 2025-08-01 |
08800039006354 - Biotex | 2025-05-02 |
08800039006361 - Biotex | 2025-05-02 |
08800039006378 - Biotex | 2025-05-02 |
08800039006385 - Biotex | 2025-05-02 |