DURASIS NXDUR0407

GUDID 00810179630010

Durasis Dural Graft

COOK BIOTECH INCORPORATED

Dura mater biomatrix implant

• Primary Device ID: 00810179630010
• NIH Device Record Key: 3dffb77c-38b8-4a0c-9fab-74e4925693b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURASIS
• Version Model Number: NXDUR0407
• Catalog Number: NXDUR0407
• Company DUNS: 945385862
• Company Name: COOK BIOTECH INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810179630010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160869

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: 2025-02-28
• Device Publish Date: 2025-02-20

On-Brand Devices [DURASIS]

• 00810179630034: Durasis Dural Graft
• 00810179630027: Durasis Dural Graft
• 00810179630010: Durasis Dural Graft
• 00810179630003: Durasis Dural Graft