DuraMend™

GUDID 00813954022482

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

COLLAGEN MATRIX, INC.

Dura mater biomatrix implant
Primary Device ID00813954022482
NIH Device Record Key6ea1b68c-7ab3-4ae7-b8c5-db0b2add5149
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraMend™
Version Model NumberNDM33
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

Width3 Inch
Width3 Inch
Width3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch
Length3 Inch
Width3 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954022482 [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™]

00813954022499Collagen Dura Substitute Membrane 4in x 5in (10.0cm x 12.5cm)
00813954022482Collagen Dura Substitute Membrane 3in x 3in (7.5cm x 7.5cm)
00813954022475Collagen Dura Substitute Membrane 2in x 2in (5.0cm x 5.0cm)
00813954022468Collagen Dura Substitute Membrane 1in x 3in (2.5cm x 7.5cm)
00813954022451Collagen Dura Substitute Membrane 1in x 1in (2.5cm x 2.5cm)

Trademark Results [DuraMend]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURAMEND
DURAMEND
87530951 not registered Live/Pending
Collagen Matrix, Inc.
2017-07-17
DURAMEND
DURAMEND
76478176 not registered Dead/Abandoned
JOHNSON & JOHNSON
2002-12-13

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