bioADAPT OUSB1EU
GUDID 00813954028019
Collagen Dental Membrane
COLLAGEN MATRIX, INC.
Collagen dental regeneration membrane| Primary Device ID | 00813954028019 |
| NIH Device Record Key | 4565655d-890d-407f-8c75-4a6f77f8fb6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | bioADAPT |
| Version Model Number | OUSB1EU |
| Catalog Number | OUSB1EU |
| 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 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| CustomerSupport@acesurgical.com | |
| Phone | 800-441-3100 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00614950028634 [Previous] |
| GS1 | 00813954028019 [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 | 2026-01-15 |
| Device Publish Date | 2026-01-07 |
On-Brand Devices [bioADAPT]
| 00813954028064 | Collagen Dental Membrane |
| 00813954028057 | Collagen Dental Membrane |
| 00813954028040 | Collagen Dental Membrane |
| 00813954028033 | Collagen Dental Membrane |
| 00813954028026 | Collagen Dental Membrane |
| 00813954028019 | Collagen Dental Membrane |
Trademark Results [bioADAPT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOADAPT 87234548 not registered Dead/Abandoned |
Healthy Directions, LLC 2016-11-11 |
 BIOADAPT 85582928 4348889 Live/Registered |
RTI SURGICAL, INC. 2012-03-28 |
 BIOADAPT 78748290 3270042 Dead/Cancelled |
Healthy Directions, LLC 2005-11-07 |
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