Primary Device ID | 10361554000722 |
NIH Device Record Key | 33aaad13-3460-418c-ae44-20428502a190 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Collagen Dressings |
Version Model Number | XXXX |
Catalog Number | XXX |
Company DUNS | 170967876 |
Company Name | Gentell, LLC |
Device Count | 300 |
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 | 10361554000722 [Primary] |
GS1 | 10361554003143 [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 | 2024-07-16 |
Device Publish Date | 2024-07-08 |
00361554000084 - Collagen Particles | 2024-08-23 Collagen Particles Wound Filler 1gram pouch |
10361554002047 - Gentell | 2024-07-22 |
10361554000081 - Gentell | 2024-07-16 |
10361554000135 - Gentell | 2024-07-16 Collagen wound dressings 7"x7" |
10361554000722 - Collagen Dressings | 2024-07-16 |
10361554000722 - Collagen Dressings | 2024-07-16 |
10361554003051 - Gentell | 2024-07-16 |
20361554000088 - Gentell | 2024-07-16 |
00361554000787 - Gentell | 2024-07-10 Collagen Particles Wound Filler 1 gram Pouch |