Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Ultrasound endoscope balloon, synthetic polymer FDA UDI
- Device Name
- This product is intended to be used in combination with the FUJIFILM ultrasonic endoscope to enclose the ultrasonic transmission medium 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
- BS-102 FDA UDI
- Description
- This product is intended to be used in combination with the FUJIFILM ultrasonic endoscope to enclose the ultrasonic transmission medium 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
- 04547410446142 FDA UDI
- 510(k) Number
- K221238 FDA UDI
- FDA Product Code
- ITX FDA UDIODG FDA UDIFDS FDA UDI
- GMDN Term
- Ultrasound endoscope balloon, synthetic polymer 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasound endoscope balloon, synthetic polymer
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasound endoscope balloon, synthetic polymer.
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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 f9fecaaa-285c-45e4-81b7-9a2fcf20eb22 36 fields · synced May 30, 2026