Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- This product is intended to be used for connecting the FUJFILM ultrasonic endoscope and the ultrasonic processor to transmit ultrasonic drive and image signals in medical facilities under the management of physicians. Do not use this product for any other purpose. This product is not intended for use on children and infants. FDA UDI
- Model / Reference
- UC-01 FDA UDI
- Description
- This product is intended to be used for connecting the FUJFILM ultrasonic endoscope and the ultrasonic processor to transmit ultrasonic drive and image signals in medical facilities under the management of physicians. Do not use this product for any other purpose. This product is not intended for use on children and infants. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410446128 FDA UDI
- 510(k) Number
- K221238 FDA UDI
- FDA Product Code
- ITX FDA UDIODG FDA UDIFDS FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI876.1500 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: Electrical-only medical device connection cable, reusable
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221238 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
- FUJIFILM Corporation
Sources (1)
- FDA UDI 071a8976-fc16-43a3-86f8-9760072db104 36 fields · synced May 30, 2026