OASIS 8213-3000-21

GUDID 00827002590922

OASIS XL

COOK BIOTECH INCORPORATED

Collagen wound matrix dressing

• Primary Device ID: 00827002590922
• NIH Device Record Key: af046b82-c8d7-4d99-a2ae-aa0c4b686c44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OASIS
• Version Model Number: G59092
• Catalog Number: 8213-3000-21
• 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

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 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	00827002590922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061711

FDA Product Code

• KGN: Dressing, wound, collagen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-31
• Device Publish Date: 2021-09-03

On-Brand Devices [OASIS]

• 10827002466279: OASIS Wound Matrix
• 10827002466231: OASIS Wound Matrix
• 00827002576100: OASIS Burn Matrix
• 00827002576094: OASIS Burn Matrix
• 00827002576087: OASIS Burn Matrix
• 10827002576077: OASIS Burn Matrix
• 10827002576060: OASIS Burn Matrix
• 10827002576053: OASIS Burn Matrix
• 10827002576046: OASIS Burn Matrix
• 10827002576039: OASIS Burn Matrix
• 10827002576022: OASIS Burn Matrix
• 10827002576015: OASIS Burn Matrix
• 00827002564664: OASIS Ultra Tri-Layer Matrix
• 10827002564654: OASIS Ultra Tri-Layer Matrix
• 00827002564640: OASIS Ultra Tri-Layer Matrix
• 10827002564630: OASIS Ultra Tri-Layer Matrix
• 10827002466262: OASIS Wound Matrix
• 10827002466224: OASIS Wound Matrix
• 10827002352459: OASIS Ultra Tri-Layer Matrix
• 10827002352442: OASIS Ultra Tri-Layer Matrix
• 10827002352435: OASIS Ultra Tri-Layer Matrix
• 10827002352428: OASIS Ultra Tri-Layer Matrix
• 00827002231207: OASIS Ultra Tri-Layer Matrix
• 10827002231198: OASIS Ultra Tri-Layer Matrix
• 10827002590929: OASIS XL
• 10827002466460: OASIS XL
• 00827002590922: OASIS XL
• 00827002466463: OASIS XL