Identity
- Trade Name
- OSCAR FDA UDI
- Generic Name
- Orthopaedic cement extractor, electric FDA UDI
- Device Name
- Ultrasonic Generator FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Ultrasonic Generator FDA UDI
Identifiers
- Catalog Number
- OS3000 FDA UDI
- Primary DI / UDI-DI
- 05060201560425 FDA UDI
- FDA Product Code
- LZV FDA UDIJDX FDA UDI
- GMDN Term
- Orthopaedic cement extractor, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.4580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic cement extractor, electric
Oscar by Orthosonics, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement extractor, electric.
- Acudriver — Exactech, Inc. · Class I
- OSCAR — Orthosonics, Ltd. · Class II
- OSCAR — Orthosonics, Ltd. · Class II
- OSCAR — Orthosonics, Ltd. · Class II
- OSCAR — Orthosonics, Ltd. · Class II
- OSCAR — Orthosonics, Ltd. · Class II
- OSCAR — Orthosonics, Ltd. · Class II
- OSCAR — Orthosonics, Ltd. · 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
- Orthosonics, Ltd.
Sources (1)
- FDA UDI 63fc2f45-9726-423f-b552-330d281a7da8 36 fields · synced May 30, 2026