Identity
- Trade Name
- KARL STORZ FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- TRAY, CYSTOSCOPE UP TO 5.5MM X 35CM DM: 16" X 3" X 1.3" FDA UDI
- Model / Reference
- KSE09046 FDA UDI
- Description
- TRAY, CYSTOSCOPE UP TO 5.5MM X 35CM DM: 16" X 3" X 1.3" FDA UDI
Identifiers
- Catalog Number
- KSE09046 FDA UDI
- Primary DI / UDI-DI
- 00817766024511 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Karl Storz by Tecomet, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tecomet, Inc
Sources (1)
- FDA UDI e0fe4ff5-fee4-4bb5-a5ee-c07cab5be296 34 fields · synced Sep 18, 2026