Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video duodenoscope, reusable FDA UDI
- Device Name
- This product is a distal end rubber cap required to be attached to certain FUJFIILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. Do not use this product for any other purposes. FDA UDI
- Model / Reference
- DC-08D FDA UDI
- Description
- This product is a distal end rubber cap required to be attached to certain FUJFIILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures. Do not use this product for any other purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410429046 FDA UDI
- FDA Product Code
- FDT FDA UDI
- GMDN Term
- Flexible video duodenoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Category: Flexible video duodenoscope, reusable
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video duodenoscope, reusable.
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- VIDEO DUODENOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO DUODENOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO DUODENOSCOPE — PENTAX of America, Inc. · Class II
- EVIS EXERA II DUODENOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA II DUODENOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA III DUODENOVIDEOSCOPE — 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 II | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 45ac1f77-539c-4f80-9935-90d8145b5c03 35 fields · synced Jun 8, 2026