DURAFORM 801480US

GUDID 10886704079491

DURAFORM Dural Graft Implant 4 Inches x 5 Inches (10.16cm x 12.7cm)

CODMAN & SHURTLEFF, INC.

Dura mater biomatrix implant

• Primary Device ID: 10886704079491
• NIH Device Record Key: 8373d540-d542-40c3-9cbd-e5baf8544a24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAFORM
• Version Model Number: 80-1480US
• Catalog Number: 801480US
• Company DUNS: 607846297
• Company Name: CODMAN & SHURTLEFF, 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

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704079491 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-23
• Device Publish Date: 2016-03-22

On-Brand Devices [DURAFORM]

• 10886704079491: DURAFORM Dural Graft Implant 4 Inches x 5 Inches (10.16cm x 12.7cm)
• 20886704079481: DURAFORM Dural Graft Implant 3 Inches x 3 Inches (7.62cm x 7.62cm)
• 10886704079477: DURAFORM Dural Graft Implant 3 Inches x 3 Inches (7.62cm x 7.62cm)
• 20886704079467: DURAFORM Dural Graft Implant 2 Inches x 2 Inches (5.08cm x 5.08cm)
• 10886704079453: DURAFORM Dural Graft Implant 2 Inches x 2 Inches (5.08cm x 5.08cm)
• 20886704079443: DURAFORM Dural Graft Implant 1 Inch x 3 Inches (2.54cm x 7.62cm)
• 10886704079439: DURAFORM Dural Graft Implant 1 Inch x 3 Inches (2.54cm x 7.62cm)
• 20886704079429: DURAFORM Dural Graft Implant 1 Inch x 1 Inch (2.54cm x 2.54cm)
• 10886704036746: DURAFORM Dural Graft Implant 4 Inches x 5 Inches (10.16cm x 12.7cm)
• 20886704036736: DURAFORM Dural Graft Implant 3 Inches x 3 Inches (7.62cm x 7.62cm)
• 10886704036722: DURAFORM Dural Graft Implant 3 Inches x 3 Inches (7.62cm x 7.62cm)
• 20886704036712: DURAFORM Dural Graft Implant 2 Inches x 2 Inches (5.08cm x 5.08cm)
• 10886704036708: DURAFORM Dural Graft Implant 2 Inches x 2 Inches (5.08cm x 5.08cm)
• 20886704036699: DURAFORM Dural Graft Implant 1 Inch x 3 Inches (2.54cm x 7.62cm)
• 10886704036685: DURAFORM Dural Graft Implant 1 Inches x 3 Inches (2.54cm x 7.62cm)
• 20886704036675: DURAFORM Dural Graft Implant 1 Inch x 1 Inch (2.54cm x 2.54cm)