DuraMatrix Suturable

GUDID 00813954020389

Collagen Dura Membrane 1in x 1in (2.5cm x 2.5cm)

COLLAGEN MATRIX, INC.

Dura mater biomatrix implant
Primary Device ID00813954020389
NIH Device Record Keyb8c06866-804e-4bd4-a975-ef1773336595
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraMatrix Suturable
Version Model NumberDMS11
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch
Length1 Inch
Width1 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954020389 [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 Number4
Public Version Date2019-11-11
Device Publish Date2015-09-16

On-Brand Devices [DuraMatrix Suturable]

00813954020426Collagen Dura Membrane 4in x 5in (10cm x 12.5cm)
00813954020419Collagen Dura Membrane 3in x 3in (7.5cm x 7.5cm)
00813954020402Collagen Dura Membrane 2in x 2in (5.0cm x 5.0cm)
00813954020396Collagen Dura Membrane 1in x 3in (2.5cm x 7.5cm)
00813954020389Collagen Dura Membrane 1in x 1in (2.5cm x 2.5cm)

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