Identity
- Trade Name
- TORS FDA UDI
- Generic Name
- Hard/soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- P4R2 - Cement 200mm Ø4mm Piercer Probe (Reusable) FDA UDI
- Model / Reference
- Series 1 FDA UDI
- Description
- P4R2 - Cement 200mm Ø4mm Piercer Probe (Reusable) FDA UDI
Identifiers
- Catalog Number
- P4R2 FDA UDI
- Primary DI / UDI-DI
- 05060634770729 FDA UDI
- FDA Product Code
- JDX FDA UDI
- GMDN Term
- Hard/soft-tissue ultrasonic surgical system 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 200 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Category: Hard/soft-tissue ultrasonic surgical system
Tors by Radley Scientific Limited — 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
- Radley Scientific Limited
Sources (1)
- FDA UDI 946cb142-b77d-49c0-a15d-e060145337ee 36 fields · synced Jun 8, 2026