Identity
- Trade Name
- Inion OTPS BioRestore™ FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Morsels 4.5 cc FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Morsels 4.5 cc FDA UDI
Identifiers
- Catalog Number
- BRS-1610 FDA UDI
- Primary DI / UDI-DI
- M224BRS16109 FDA UDI
- FDA Product Code
- LYC FDA UDIMQV FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI888.3045 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Synthetic bone graft
Inion OTPS BioRestore™ by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
Cleared under the same submission
K070784 also covers:
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
- Inion , Ltd.
Sources (1)
- FDA UDI 01d06e29-4057-4f16-9abd-76d8f8ccc3fa 36 fields · synced May 31, 2026