bioKOTE OUSKTS

GUDID 10813954028566

Collagen Dental Dressing

COLLAGEN MATRIX, INC.

General oral wound dressing, animal-derived

• Primary Device ID: 10813954028566
• NIH Device Record Key: 5895aa5d-953d-404b-9a7e-169529f25246
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioKOTE
• Version Model Number: OUSKTS
• Catalog Number: OUSKTS
• 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: 800-441-3100
• Email: CustomerSupport@acesurgical.com
• Phone: 800-441-3100
• Email: CustomerSupport@acesurgical.com
• Phone: 800-441-3100
• Email: CustomerSupport@acesurgical.com
• Phone: 800-441-3100
• Email: CustomerSupport@acesurgical.com
• Phone: 800-441-3100
• Email: CustomerSupport@acesurgical.com
• Phone: 800-441-3100
• Email: CustomerSupport@acesurgical.com
• Phone: 800-441-3100
• Email: CustomerSupport@acesurgical.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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950007714 [Previous]
GS1	00813954028569 [Primary]
GS1	10813954028566 [Package]; Contains: 00813954028569; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2026-03-17
• Device Publish Date: 2026-03-09

Devices Manufactured by COLLAGEN MATRIX, INC.

• 00813954028484 - XENOFY-P: 2026-03-20 Porcine Anorganic Bone Graft
• 00813954028491 - XENOFY-P: 2026-03-20 Porcine Anorganic Bone Graft
• 00813954028507 - XENOFY-P: 2026-03-20 Porcine Anorganic Bone Graft
• 00813954028514 - XENOFY-P: 2026-03-20 Porcine Anorganic Bone Graft
• 00813954028521 - XENOFY-P: 2026-03-20 Porcine Anorganic Bone Graft
• 00813954028538 - XENOFY-P: 2026-03-20 Porcine Anorganic Bone Graft
• 10813954028436 - Tissue Specialists Resorbable Collagen Plug: 2026-03-17 Resorbable Collagen Plug
• 10813954028443 - Tissue Specialists Resorbable Collagen Tape: 2026-03-17 Resorbable Collagen Tape