bioMAINTAIN OUSA3EU

GUDID 00813954028347

Collagen Dental Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane

• Primary Device ID: 00813954028347
• NIH Device Record Key: 030025ae-7dc8-476f-995c-545d39a65196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioMAINTAIN
• Version Model Number: OUSA3EU
• Catalog Number: OUSA3EU
• 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
• 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
• 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	00614950028627 [Previous]
GS1	00813954028347 [Primary]

FDA Product Code

• NPL: Barrier, Animal Source, Intraoral

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

On-Brand Devices [bioMAINTAIN]

• 00813954028378: Collagen Dental Membrane
• 00813954028361: Collagen Dental Membrane
• 00813954028354: Collagen Dental Membrane
• 00813954028347: Collagen Dental Membrane
• 00813954028330: Collagen Dental Membrane
• 00813954028323: Collagen Dental Membrane