Curagen collagen wound dressing

GUDID 04714691213606

MAXIGEN BIOTECH INC.

General oral wound dressing, animal-derived
Primary Device ID04714691213606
NIH Device Record Key3baa4ae9-ce9e-4a28-a380-f2eee1b6e208
Commercial Distribution StatusIn Commercial Distribution
Brand NameCuragen collagen wound dressing
Version Model NumberHAD204030
Company DUNS657266016
Company NameMAXIGEN BIOTECH INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104714691213606 [Unit of Use]
GS104714691850443 [Primary]

FDA Product Code

OLROral Wound Dressing

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-26
Device Publish Date2024-11-18

On-Brand Devices [Curagen collagen wound dressing]

04714691850467HAD001020
04714691213590HAD001520
04714691213606HAD204030

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.