DurAdapt DFCS11

GUDID 00813954025865

Dural Graft Implant

COLLAGEN MATRIX, INC.

Dura mater graft, bovine

• Primary Device ID: 00813954025865
• NIH Device Record Key: 0f3d450c-1064-40aa-8924-320727687086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DurAdapt
• Version Model Number: DFCS11
• Catalog Number: DFCS11
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954025865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152481

FDA Product Code

• GXQ: Dura Substitute

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [DurAdapt]

• 00813954025902: Dural Graft Implant
• 00813954025896: Dural Graft Implant
• 00813954025889: Dural Graft Implant
• 00813954025872: Dural Graft Implant
• 00813954025865: Dural Graft Implant