DuraMatrix

GUDID 00813954020198

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

COLLAGEN MATRIX, INC.

Dura mater biomatrix implant
Primary Device ID00813954020198
NIH Device Record Key47e3a81d-5780-4dd0-9552-fd92d85dc3c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraMatrix
Version Model NumberCDSM13
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

Length1 Inch
Length1 Inch
Length1 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch
Width3 Inch
Length1 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954020198 [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]

00813954020228Collagen Dura Substitute Membrane 4in x 5in (10.0cm x 12.5cm)
00813954020211Collagen Dura Substitute Membrane 3in x 3in (7.5cm x 7.5cm)
00813954020204Collagen Dura Substitute Membrane 2in x 2in (5cm x 5cm)
00813954020198Collagen Dura Substitute Membrane 1in x 3in (2.5cm x 7.5cm)
00813954020181Collagen Dura Substitute Membrane 1in x 1in (2.5cm x 2.5cm)

Trademark Results [DuraMatrix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURAMATRIX
DURAMATRIX
85657920 4327230 Live/Registered
Collagen Matrix, Inc.
2012-06-21
DURAMATRIX
DURAMATRIX
85243608 4022800 Dead/Cancelled
Duragraft, LLC
2011-02-16

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