Identity
- Trade Name
- SILVER SCOPE FDA UDI
- Generic Name
- Flexible video colonoscope, reusable FDA UDI
- Device Name
- Standard Colonoscope 3.8/1600 NTSC FDA UDI
- Model / Reference
- 13925NKS FDA UDI
- Description
- Standard Colonoscope 3.8/1600 NTSC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551003695 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
No
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
Silver Scope by Karl Storz GmbH & Co. KG — 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
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- Endoch — Endoch Inc · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- PENTAX — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM 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
- Karl Storz GmbH & Co. KG
Sources (1)
- FDA UDI b3f672c8-08ae-4bd2-84b2-ee95e2477df3 33 fields · synced May 31, 2026