ColActive® Plus 2"x2"

GUDID 00825439011195

Collagen dressing

Covalon Technologies Ltd

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00825439011195
• NIH Device Record Key: 03c476df-9ed1-4c32-a028-0e87f17ae85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColActive® Plus 2"x2"
• Version Model Number: 5550220
• Company DUNS: 206936101
• Company Name: Covalon Technologies Ltd
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439011188 [Primary]
GS1	00825439011195 [Package]; Contains: 00825439011188; Package: Carton [10 Units]; In Commercial Distribution
GS1	10825439011208 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060804

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2022-12-08
• Device Publish Date: 2022-11-30

Devices Manufactured by Covalon Technologies Ltd

• 00825439011393 - CovaWound™ Silicone 10x10: 2024-04-16 Self-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
• 00825439011478 - CovaWound™ Silicone 7.5x7.5: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing
• 00825439011515 - CovaWound™ Silicone 12x12: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing
• 00825439011553 - CovaWound™ Silicone 15x20: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing
• 00825439012055 - CovaWound™ Silicone 18x18: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border