OSTEO-Tape

GUDID 10850011613129

Dental Wound Dressing

COLLAGEN MATRIX, INC.

General oral wound dressing, animal-derived
Primary Device ID10850011613129
NIH Device Record Key068a9fc6-63c0-4cd7-b107-0c561424ed4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSTEO-Tape
Version Model NumberOSTEOTAPE
Company DUNS176262442
Company NameCOLLAGEN MATRIX, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100850011613122 [Unit of Use]
GS110850011613129 [Primary]

FDA Product Code

KGNDressing, Wound, Collagen

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

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