OSTEO-Derm Enhanced

GUDID 00850011613160

Resorbable Collagen Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane
Primary Device ID00850011613160
NIH Device Record Keyae6e115a-dd23-4ce0-b992-759564d307ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSTEO-Derm Enhanced
Version Model NumberOSTEODE30x40
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
GS100850011613160 [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 Enhanced]

00850011613160Resorbable Collagen Membrane
00850011613153Resorbable Collagen Membrane
00850011613146Resorbable Collagen Membrane

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