Identity
- Trade Name
- InnoWave FDA UDI
- Generic Name
- Surgical instrument washer/disinfector (chemical/thermal) FDA UDI
- Device Name
- The InnoWave PCF Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide ultrasonic cleaning and low-level thermal disinfection of surgical instruments, including complex lumen-cannulated devices, such as robotic surgical instruments. FDA UDI
- Model / Reference
- PCF FDA UDI
- Description
- The InnoWave PCF Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide ultrasonic cleaning and low-level thermal disinfection of surgical instruments, including complex lumen-cannulated devices, such as robotic surgical instruments. FDA UDI
Identifiers
- Catalog Number
- IWPCF FDA UDI
- Primary DI / UDI-DI
- 00724995152710 FDA UDI
- FDA Product Code
- MEC FDA UDI
- GMDN Term
- Surgical instrument washer/disinfector (chemical/thermal) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6992 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Surgical instrument washer/disinfector (chemical/thermal)
InnoWave by Medisafe Uk 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
- Medisafe Uk Limited
Sources (1)
- FDA UDI 12385102-b3da-4850-9f4d-8ef87c5af8bf 35 fields · synced May 30, 2026