Wound Matrix FWM-1

GUDID 10827002584218

Flowable Wound Matrix

COOK BIOTECH INCORPORATED

Collagen wound matrix dressing

• Primary Device ID: 10827002584218
• NIH Device Record Key: beb59aad-826d-4db7-8c52-b727461152c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wound Matrix
• Version Model Number: G58421
• Catalog Number: FWM-1
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• 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.
• 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.
• 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	10827002584218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160136

FDA Product Code

• KGN: Dressing, wound, collagen

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: 2020-12-18
• Device Publish Date: 2020-12-10

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• 00810179630034 - DURASIS: 2025-02-28 Durasis Dural Graft
• 10827002349770 - Biodesign: 2024-07-08 Biodesign Duraplasty Graft
• 10827002349787 - Biodesign: 2024-07-08 Biodesign Duraplasty Graft
• 10827002349794 - Biodesign: 2024-07-08 Biodesign Duraplasty Graft
• 10827002349800 - Biodesign: 2024-07-08 Biodesign Duraplasty Graft