Primary Device ID | 00812593021818 |
NIH Device Record Key | 7e9135e3-0197-4ef3-8328-924e652b8949 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NeoForm CWM |
Version Model Number | NFCWM-005 |
Company DUNS | 832270370 |
Company Name | Biogennix, LLC |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00812593021818 [Primary] |
KGN | Wound Dressing With Animal-Derived Material(S) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-13 |
Device Publish Date | 2024-06-05 |
00812593021726 - bYomed Surgical MatriX | 2024-11-13 |
00812593021818 - NeoForm CWM | 2024-06-13 |
00812593021818 - NeoForm CWM | 2024-06-13 |
00812593021771 - Agilon Surgical Matrix | 2024-04-01 |
00812593021689 - PURvital | 2024-03-18 |
00812593021696 - PURvital | 2024-03-18 |
00812593021702 - PURvital | 2024-03-18 |
00812593021719 - PURvital | 2024-03-18 |
00812593021580 - ossFX | 2023-12-21 ossFX Fusion Kit |