Identity
- Trade Name
- OsteoProbe Measurement Kit FDA UDI
- Generic Name
- Bone microindentation resistance measurement system FDA UDI
- Device Name
- OsteoProbe Measurement Kit containing 1 sterile tip, 1 sterile cover, and 1 reference material block FDA UDI
- Model / Reference
- OPD-907 FDA UDI
- Description
- OsteoProbe Measurement Kit containing 1 sterile tip, 1 sterile cover, and 1 reference material block FDA UDI
Identifiers
- Catalog Number
- OPD-907 FDA UDI
- Primary DI / UDI-DI
- 00860001719390 FDA UDI
- 510(k) Number
- DEN210013 FDA UDI
- FDA Product Code
- QGQ FDA UDI
- GMDN Term
- Bone microindentation resistance measurement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone microindentation resistance measurement system
OsteoProbe Measurement Kit by Active Life Scientific, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Active Life Scientific, Inc.
Sources (2)
- FDA UDI 6b05478c-9df6-4551-b6b2-344d0f28df79 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026