Identity
- Trade Name
- Orthoss® FDA UDI
- Generic Name
- Bone matrix implant, animal-derived, bioabsorbable FDA UDI
- Model / Reference
- 500501 FDA UDI
Identifiers
- Catalog Number
- - FDA UDI
- Primary DI / UDI-DI
- 07610221013104 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, animal-derived, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 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
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 2 Centimeter FDA UDIHeight — 1 Centimeter FDA UDIDepth — 1 Centimeter FDA UDI
Category: Bone matrix implant, animal-derived, bioabsorbable
Orthoss® by Geistlich Pharma AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Geistlich Pharma AG
Sources (1)
- FDA UDI 1f1d7d6e-8518-4831-9741-a674c74668c5 34 fields · synced Jun 8, 2026