Identity
- Trade Name
- C11x/8-5 MHz FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Diagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- P24308-04 FDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Catalog Number
- P24308 FDA UDI
- Primary DI / UDI-DI
- 00841517108588 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
Yes
FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-held
C11x/8-5 MHz by Fujifilm Sonosite, Inc. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (2)
- FDA UDI 7b89cfa7-b6b6-4b98-b4ee-efa40c363a36 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 2, 2026