WOUN'DRES 1166

GUDID 00311701161526

Coloplast A/S

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00311701161526
• NIH Device Record Key: 4e9bf9ce-ab97-455f-8ce7-73175e48f56e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WOUN'DRES
• Version Model Number: 1166
• Catalog Number: 1166
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com

Device Dimensions

• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce
• Total Volume: 1 Fluid Ounce

Device Identifiers

Device Issuing Agency	Device ID
GS1	00311701161021 [Primary]
GS1	00311701161526 [Package]; Contains: 00311701161953; Package: Shipper Box [6 Units]; In Commercial Distribution
GS1	00311701161953 [Package]; Contains: 00311701161021; Package: Retail Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991202

FDA Product Code

• MGQ: Dressing, wound and burn, hydrogel w/drug and/or biologic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-02
• Device Publish Date: 2022-04-22