Identity
- Trade Name
- CW 4MHz Ultrasonic Probe FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- CW 4MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System. FDA UDI
- Model / Reference
- CW 4MHz Ultrasonic Probe FDA UDI
- Description
- CW 4MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System. FDA UDI
Identifiers
- Catalog Number
- 23-636 FDA UDI
- Primary DI / UDI-DI
- 07290016734058 FDA UDI
- 510(k) Number
- K062578 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-held
CW 4MHz Ultrasonic Probe by Rimed Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062578 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 II | Pending data |
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Manufacturer
- Manufacturer
- Rimed Ltd.
Sources (1)
- FDA UDI 6c369b77-4aeb-4611-a2f9-db64cb33b518 35 fields · synced May 30, 2026