Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video colonoscope, reusable FDA UDI
- Device Name
- This product is a medical Endoscope for the lower digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the rectum and large intestine at medical facilities under management of physicians. FDA UDI
- Model / Reference
- EC-450LP5 FDA UDI
- Description
- This product is a medical Endoscope for the lower digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the rectum and large intestine at medical facilities under management of physicians. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410330946 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Flexible video colonoscope, 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Flexible video colonoscope, reusable
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PENTAX — HOYA CORPORATION · Class II
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- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · 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 878efac3-a8a4-41de-bce2-77021e126eda 35 fields · synced Jun 8, 2026