DuraMend-Onlay™

GUDID 00813954022543

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

COLLAGEN MATRIX, INC.

Dura mater biomatrix implant

• Primary Device ID: 00813954022543
• NIH Device Record Key: 313bb25b-9fa9-482b-89ed-e11cad1f06e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraMend-Onlay™
• Version Model Number: NDMO33
• 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

• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch
• Length: 3 Inch
• Width: 3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954022543 [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: 3
• Public Version Date: 2019-11-11
• Device Publish Date: 2018-04-05

On-Brand Devices [DuraMend-Onlay™]

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