ColActive® Plus 7"x7"

GUDID 00825439011256

Collagen dressing

Covalon Technologies Ltd

Collagen wound matrix dressing

• Primary Device ID: 00825439011256
• NIH Device Record Key: 938d6f31-54a0-4005-840e-9d8dae748402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColActive® Plus 7"x7"
• Version Model Number: 5550770
• 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: 7 Inch
• Width: 7 Inch
• Length: 7 Inch
• Width: 7 Inch
• Length: 7 Inch
• Width: 7 Inch
• Length: 7 Inch
• Width: 7 Inch
• Length: 7 Inch
• Width: 7 Inch
• Length: 7 Inch
• Width: 7 Inch
• Length: 7 Inch
• Width: 7 Inch
• Length: 7 Inch
• Width: 7 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	00825439011249 [Primary]
GS1	00825439011256 [Package]; Contains: 00825439011249; Package: Carton [10 Units]; In Commercial Distribution
GS1	10825439011260 [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

• 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: 2024-04-16 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