CovaWound™ Silicone 10x10

GUDID 00825439011393

Self-Adherent Soft Silicone Foam Dressing with Border

Covalon Technologies Ltd

Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial

• Primary Device ID: 00825439011393
• NIH Device Record Key: b12fc202-2038-48c2-829b-0fa5c52bc534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CovaWound™ Silicone 10x10
• Version Model Number: 1011010
• Company DUNS: 206936101
• Company Name: Covalon Technologies Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439011386 [Primary]
GS1	00825439011393 [Package]; Contains: 00825439011386; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [CovaWound™ Silicone 10x10]

• 00825439011492: Self-Adherent Soft Silicone Foam Dressing
• 00825439014370: Self-Adherent Soft Silicone Foam Dressing with Border (Lite)
• 00825439011393: Self-Adherent Soft Silicone Foam Dressing with Border