COOK C-ECM-PWD-100MG

GUDID 20827002448517

Powder Extracellular Matrix

COOK BIOTECH INCORPORATED

Biochemically-interactive dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 20827002448517
• NIH Device Record Key: 0cbf5d76-0324-4ef8-a431-089f2bfa635b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COOK
• Version Model Number: G44851
• Catalog Number: C-ECM-PWD-100MG
• 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

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

Operating and Storage Conditions

• 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 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20827002448517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152033

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: 2019-04-25
• Device Publish Date: 2019-04-17

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