BioBridge Collagen Matrix (TM) PRT0070

GUDID B218PRT0070

The Fibralign BioBridge® Collagen Matrix is a sterile, thin collagen ribbon made of highly purified pepsin treated Type 1 porcine collagen and features Fibralign’s Nanoweave® technology. It is provided in single use packaging with five devices included in each package.

Fibralign Corporation

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• Primary Device ID: B218PRT0070
• NIH Device Record Key: 60531ffa-b7fc-493c-8162-42da544b9933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioBridge Collagen Matrix (TM)
• Version Model Number: PRT0070
• Catalog Number: PRT0070
• Company DUNS: 023369802
• Company Name: Fibralign Corporation
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: info@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com
• Phone: 415-902-4721
• Email: gking@fibralignbio.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B218PRT0070 [Primary]
HIBCC	B218PRT00700 [Package]; Package: Tyvek [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151083

FDA Product Code

• OWY: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

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: 2021-01-07
• Device Publish Date: 2020-12-30