Identity
- Trade Name
- Endoch FDA UDI
- Generic Name
- Flexible video gastroscope, reusable FDA UDI
- Device Name
- Video Gastroscope FDA UDI
- Model / Reference
- GS-330 FDA UDI
- Description
- Video Gastroscope FDA UDI
Identifiers
- Catalog Number
- GS-330 FDA UDI
- Primary DI / UDI-DI
- GS3300 FDA UDI
- FDA Product Code
- FDS FDA UDI
- GMDN Term
- Flexible video gastroscope, 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video gastroscope, reusable
Endoch by Endoch Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PENTAX — HOYA CORPORATION · Class II
- VIDEO GASTROSCOPE — PENTAX of America, Inc. · Class II
- PENTAX — HOYA CORPORATION · Class II
- VIDEO SIGMOIDOSCOPE — 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
- Endoch Inc
Sources (1)
- FDA UDI 0a118c56-b7ae-4259-9030-df7168dc30a5 34 fields · synced May 30, 2026