DermaCol/Ag Healogics by DermaRite

GUDID 00714196933522

DERMARITE INDUSTRIES LLC

Collagen wound matrix dressing
Primary Device ID00714196933522
NIH Device Record Key3a8754b9-3ed6-4059-a38d-2990019674a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermaCol/Ag Healogics by DermaRite
Version Model Number93352
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100714196933522 [Primary]
GS101714196933521 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2020-01-28

Devices Manufactured by DERMARITE INDUSTRIES LLC

71419624712486 - DermaSyn2024-10-29
01714196500150 - SilvaKollagen Gel2023-10-12 Silver collagen wound gel (42 g tube) is a medical hydrolysate of collagen with silver oxide. OTC for minor burns, superficial c
00714196390028 - AquaDerm2022-05-10
00714196391780 - DermaFilm thin with Border2021-09-20
00714196390004 - Adhesive Tape Remover Pads2021-09-17
00714196390042 - AquaDerm2021-09-17
00714196390066 - AquaRite Extra CMC2021-09-17
00714196390080 - AquaRite Extra CMC2021-09-17

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