DuraMend-Onlay™

GUDID 00813954022529

Collagen Dura Substitute Membrane 1in x 3in (2.5cm x 7.5cm)

COLLAGEN MATRIX, INC.

Dura mater biomatrix implant
Primary Device ID00813954022529
NIH Device Record Key98578f84-c0c0-48b6-b96e-c785363b40b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraMend-Onlay™
Version Model NumberNDMO13
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

Width1 Inch
Width1 Inch
Width1 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch
Length3 Inch
Width1 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954022529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXQDura Substitute

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-11
Device Publish Date2018-04-05

On-Brand Devices [DuraMend-Onlay™]

00813954022567Collagen Dura Substitute Membrane 5in x 7in (12.5cm x 17.5cm)
00813954022550Collagen Dura Substitute Membrane 4in x 5in (10.0cm x 12.5cm)
00813954022543Collagen Dura Substitute Membrane 3in x 3in (7.5cm x 7.5cm)
00813954022536Collagen Dura Substitute Membrane 2in x 2in (5.0cm x 5.0cm)
00813954022529Collagen Dura Substitute Membrane 1in x 3in (2.5cm x 7.5cm)
00813954022512Collagen Dura Substitute Membrane 1in x 1in (2.5cm x 2.5cm)

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