| Primary Device ID | 00361554000084 |
| NIH Device Record Key | 0ab9de80-08dd-4d8b-bf60-80df61562da1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Collagen Particles |
| Version Model Number | xxxx |
| Catalog Number | xxx |
| Company DUNS | 170967876 |
| Company Name | Gentell, LLC |
| Device Count | 50 |
| 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 |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com | |
| Phone | 6474088343 |
| sri.divya@gentell.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00361554000084 [Primary] |
| GS1 | 10361554000777 [Unit of Use] |
| 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 | 2024-08-23 |
| Device Publish Date | 2024-08-15 |