FIBRACOL® PLUS 2983

GUDID 25051978001109

Collagen Wound Dressing with Alginate

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Collagen wound matrix dressing

• Primary Device ID: 25051978001109
• NIH Device Record Key: 6ca98f03-cd82-4937-b764-e98ec35e5b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBRACOL® PLUS
• Version Model Number: 2983
• Catalog Number: 2983
• Company DUNS: 211352227
• Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter
• Width: 10.2 Centimeter
• Length: 22.2 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051978001102 [Primary]
GS1	25051978001109 [Package]; Contains: 15051978001102; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-09-24

On-Brand Devices [FIBRACOL® PLUS]

• 25051978001116: Collagen Wound Dressing with Alginate
• 25051978001109: Collagen Wound Dressing with Alginate
• 25051978001093: Collagen Wound Dressing with Alginate
• 25051978001086: Collagen Wound Dressing with Alginate