bioXEN OUSM3SEU
GUDID 00813954028194
Bone Graft Particulate
COLLAGEN MATRIX, INC.
Dental bone matrix implant, animal-derived| Primary Device ID | 00813954028194 |
| NIH Device Record Key | e1ed6360-9648-41e9-8c94-3408443891db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | bioXEN |
| Version Model Number | OUSM2SEU |
| Catalog Number | OUSM3SEU |
| 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 | |
| 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 |
| 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 | 00614950028467 [Previous] |
| GS1 | 00813954028194 [Primary] |
FDA Product Code
| NPM | Bone Grafting Material, Animal Source |
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 [bioXEN]
| 00813954028309 | Bone Graft Particulate |
| 00813954028293 | Bone Graft Particulate |
| 00813954028286 | Bone Graft Particulate |
| 00813954028279 | Bone Graft Particulate |
| 00813954028262 | Bone Graft Particulate |
| 00813954028255 | Bone Graft Particulate |
| 00813954028248 | Bone Graft Particulate |
| 00813954028231 | Bone Graft Particulate |
| 00813954028224 | Bone Graft Particulate |
| 00813954028217 | Bone Graft Particulate |
| 00813954028200 | Bone Graft Particulate |
| 00813954028194 | Bone Graft Particulate |
| 00813954028187 | Bone Graft Particulate |
| 00813954028170 | Bone Graft Particulate |
Trademark Results [bioXEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOXEN 79005023 not registered Dead/Cancelled |
BIOTA BITKISEL ILAÃ VE KOZMETIK LABORATUARLARI A.S. 2004-08-13 |
 BIOXEN 77894960 4392567 Live/Registered |
BIOTA BITKISEL KOZMETIK LABORATUARLARI TICARET LIMITED SIRKETI 2009-12-16 |
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