Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video bronchoscope, reusable FDA UDI
- Device Name
- The suction button of our endoscope is installed, and the body fluid and blood, etc. are sucked from the inside of the body. Do not use this product for any other purpose. FDA UDI
- Model / Reference
- SB-500B/D FDA UDI
- Description
- The suction button of our endoscope is installed, and the body fluid and blood, etc. are sucked from the inside of the body. Do not use this product for any other purpose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410093292 FDA UDI
- FDA Product Code
- FFY FDA UDI
- GMDN Term
- Flexible video bronchoscope, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video bronchoscope, reusable
Fujifilm by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- VIDEO BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc. · Class II
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- EVIS EXERA II BRONCHOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 91153fa8-5030-4020-99a3-5d269140ef56 35 fields · synced May 30, 2026