OSTEO-Derm

GUDID 00850011613047

Resorbable Collagen Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane
Primary Device ID00850011613047
NIH Device Record Key51883881-068c-4088-b60b-1ee1352ae7cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSTEO-Derm
Version Model NumberOSTEOD20x30
Company DUNS176262442
Company NameCOLLAGEN MATRIX, 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 Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011613047 [Primary]

FDA Product Code

NPLBarrier, Animal Source, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-28
Device Publish Date2019-10-18

On-Brand Devices [OSTEO-Derm]

00850011613054Resorbable Collagen Membrane
00850011613047Resorbable Collagen Membrane
00850011613030Resorbable Collagen Membrane

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