DurAdapt DFCS45

GUDID 00813954025902

Dural Graft Implant

COLLAGEN MATRIX, INC.

Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine

• Primary Device ID: 00813954025902
• NIH Device Record Key: 7fc8ae9d-b976-4cae-a648-0228a24ee603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DurAdapt
• Version Model Number: DFCS45
• Catalog Number: DFCS45
• 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
• 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	00813954025902 [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