HealiAid Dental Collagen Wound Dressing

GUDID 04714691213019

MAXIGEN BIOTECH INC.

General oral wound dressing, animal-derived
Primary Device ID04714691213019
NIH Device Record Key8712eb24-c9c4-416c-b80f-de3e02c078ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealiAid Dental Collagen Wound Dressing
Version Model NumberHAD152005
Company DUNS657266016
Company NameMAXIGEN BIOTECH INC.
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104714691213019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-02-08
Device Publish Date2024-01-31

On-Brand Devices [HealiAid Dental Collagen Wound Dressing]

04714691213125HAD001520
04714691213118HAD001020
04714691213101HAD100100
04714691213095HAD505030
04714691213088HADB304030
04714691213071HAD204030
04714691213064HADB253030
04714691213057HADB152030
04714691213040HAD304005
04714691213033HAD253005
04714691213026HAD203005
04714691213019HAD152005
04714691213460HAD001020
04714691850290HAD001520
04714691850283HAD001020

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