Identity
- Trade Name
- MECTRON FDA UDI
- Generic Name
- Ultrasonic surgical system torque wrench, reusable FDA UDI
- Device Name
- PS MEDICAL + TORQUE WRENCH is torque wrench used for tightening inserts to the Mectron ultrasonic handpieces. FDA UDI
- Model / Reference
- PS MEDICAL + TORQUE WRENCH FDA UDI
- Description
- PS MEDICAL + TORQUE WRENCH is torque wrench used for tightening inserts to the Mectron ultrasonic handpieces. FDA UDI
Identifiers
- Catalog Number
- 02900116-001 FDA UDI
- Primary DI / UDI-DI
- E322029001160010 FDA UDI
- 510(k) Number
- K153743 FDA UDI
- FDA Product Code
- HWE FDA UDIHBE FDA UDIERL FDA UDIDZI FDA UDIJDX FDA UDI
- GMDN Term
- Ultrasonic surgical system torque wrench, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.4310 FDA UDI874.4250 FDA UDI872.4120 FDA UDI888.4580 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic surgical system torque wrench, reusable
Mectron by Mectron Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153743 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mectron Spa
Sources (1)
- FDA UDI 0bb5fb88-0e96-4c0d-8278-ccc85b469689 36 fields · synced May 30, 2026