BioStrip BIOSTRIP

GUDID 10813954027842

Resorbable Collagen Strip

COLLAGEN MATRIX, INC.

General oral wound dressing, animal-derived

• Primary Device ID: 10813954027842
• NIH Device Record Key: 54856eb4-624c-49eb-a6d6-3a41c8e596ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioStrip
• Version Model Number: BIOSTRIP
• Catalog Number: BIOSTRIP
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, INC.
• 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

Customer Support Contacts

• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com
• Phone: 1-888-246-8338
• Email: customercare@biohorizons.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950028405 [Previous]
GS1	00813954027845 [Primary]
GS1	10813954027842 [Package]; Contains: 00813954027845; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2026-01-14
• Device Publish Date: 2026-01-06

Devices Manufactured by COLLAGEN MATRIX, INC.

• 00813954027470 - RCM6: 2026-01-15 Resorbable Collagen Membrane
• 00813954027487 - RCM6: 2026-01-15 Resorbable Collagen Membrane
• 00813954027494 - RCM6: 2026-01-15 Resorbable Collagen Membrane
• 00813954027739 - NuOss: 2026-01-15 Anorganic Bovine Bone Cancellous
• 00813954027746 - NuOss: 2026-01-15 Anorganic Bovine Bone Cancellous
• 00813954027753 - NuOss: 2026-01-15 Anorganic Bovine Bone Cancellous
• 00813954027760 - NuOss: 2026-01-15 Anorganic Bovine Bone Cancellous
• 00813954027777 - NuOss: 2026-01-15 Anorganic Bovine Bone Cancellous