CovaWound™ Silicone 12.5x12.5

GUDID 00825439011416

Self-Adherent Soft Silicone Foam Dressing with Border

Covalon Technologies Ltd

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

• Primary Device ID: 00825439011416
• NIH Device Record Key: 44d18ded-31f9-4268-b6f9-0984d4e2b31b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CovaWound™ Silicone 12.5x12.5
• Version Model Number: 1011212
• 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: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 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	00825439011409 [Primary]
GS1	00825439011416 [Package]; Contains: 00825439011409; 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

Devices Manufactured by Covalon Technologies Ltd

• 00825439017487 - CovaClear™ IV Cover 4x4: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 00825439017500 - CovaClear™ IV Cover 6x7: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 00825439017524 - CovaClear™ IV Cover 10x12: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 00825439017548 - CovaClear™ IV 10x12: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 00825439011393 - CovaWound™ Silicone 10x10: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
• 00825439011416 - CovaWound™ Silicone 12.5x12.5: 2024-04-16Self-Adherent Soft Silicone Foam Dressing with Border
• 00825439011416 - CovaWound™ Silicone 12.5x12.5: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
• 00825439011430 - CovaWound™ Silicone 15x15: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
• 00825439011454 - CovaWound™ Silicone 15x20: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border