Identity
- Trade Name
- VIDEO COLONOSCOPE FDA UDI
- Generic Name
- Flexible video colonoscope, reusable FDA UDI
- Device Name
- VIDEO COLONOSCOPE - PTAH FDA UDI
- Model / Reference
- EC38-V10CL FDA UDI
- Description
- VIDEO COLONOSCOPE - PTAH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333244652 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video colonoscope, reusable
Video Colonoscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video colonoscope, reusable.
- PENTAX — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Endoch — Endoch Inc · Class II
- PENTAX — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- EVIS EXERA lll COLONOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- PENTAX Medical — HOYA 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
- PENTAX of America, Inc.
Sources (1)
- FDA UDI 1328f9b7-3887-44f2-87a7-516b4cf3b800 33 fields · synced May 30, 2026