OASIS Micro C-ECM-PWD-200MG

GUDID 20827002448524

Micronized Wound Matrix

COOK BIOTECH INCORPORATED

Biochemically-interactive dressing

• Primary Device ID: 20827002448524
• NIH Device Record Key: 148ef890-85f0-4c90-8ce7-5ae1ae0233d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OASIS Micro
• Version Model Number: G44852
• Catalog Number: C-ECM-PWD-200MG
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20827002448524 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-09
• Device Publish Date: 2019-04-17

On-Brand Devices [OASIS Micro]

• 20827002448548: Micronized Wound Matrix
• 20827002448531: Micronized Wound Matrix
• 20827002448524: Micronized Wound Matrix
• 20827002587643: Micronized Wound Matrix
• 20827002587636: Micronized Wound Matrix
• 20827002587629: Micronized Wound Matrix