Identity
- Trade Name
- OUSIA bioXEN FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- bioXEN Cancellous 0.6cc 0.25-1mm Particulate FDA UDI
- Model / Reference
- OUSM1SEU FDA UDI
- Description
- bioXEN Cancellous 0.6cc 0.25-1mm Particulate FDA UDI
Identifiers
- Catalog Number
- OUSM1SEU FDA UDI
- Primary DI / UDI-DI
- 00614950028443 FDA UDI
- FDA Product Code
- NPM FDA UDI
- GMDN Term
- Dental bone matrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.6 Milliliter FDA UDI
Category: Dental bone matrix implant, animal-derived
OUSIA bioXEN by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- A-graft®[Bone grafting material, Animal source] — HIOSSEN INC. · Class II
- SYMBIOS — COLLAGEN MATRIX, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI dad1de85-a99e-4380-917c-263520633fd2 36 fields · synced May 30, 2026