DuraMatrix Onlay

GUDID 00813954020259

Collagen Dura Substitute Membrane 2in x 2in (5cm x 5cm)

COLLAGEN MATRIX, INC.

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Primary Device ID	00813954020259
NIH Device Record Key	3dffe6eb-d769-4513-8258-87e49e83a0e5
Commercial Distribution Status	In Commercial Distribution
Brand Name	DuraMatrix Onlay
Version Model Number	CDSLM22
Company DUNS	176262442
Company Name	COLLAGEN MATRIX, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	2 Inch
Length	2 Inch
Length	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch
Width	2 Inch
Length	2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954020259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K061487

FDA Product Code

GXQ	Dura Substitute

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-11-11
Device Publish Date	2015-09-16

On-Brand Devices [DuraMatrix Onlay]

00813954020280	Collagen Dura Substitute Membrane 5in x 7in (12.5cm x 17.5cm)
00813954020273	Collagen Dura Substitute Membrane 4in x 5in (10.0cm x 12.5cm)
00813954020266	Collagen Dura Substitute Membrane 3in x 3in (7.5cm x 7.5cm)
00813954020259	Collagen Dura Substitute Membrane 2in x 2in (5cm x 5cm)
00813954020242	Collagen Dura Substitute Membrane 1in x 3in (2.5cm x 7.5cm)
00813954020235	Collagen Dura Substitute Membrane 1in x 1in (2.5cm x 2.5cm)