Identity
- Trade Name
- Zutron Medical FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Vented Bag, Transport Tote, Suction Tubing with Scallop Connectors FDA UDI
- Model / Reference
- Endoscopy Procedure Kit FDA UDI
- Description
- Endoscopy Combo Kit-Basin, Air/Water Suction Biopsy Valves and Auxiliary Water, Gauze, Sponges, Lube, Vent Bags, Channel Cleaning Brush with Valve Brush, Scope Tip Protector, Vented Bag, Transport Tote, Suction Tubing with Scallop Connectors FDA UDI
Identifiers
- Catalog Number
- ZUTR40118 FDA UDI
- Primary DI / UDI-DI
- 00817658023387 FDA UDI
- FDA Product Code
- NWU FDA UDI
- GMDN Term
- Endoscopy preparation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Zutron Medical by Zutron Medical, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Zutron Medical, L.l.c.
Sources (1)
- FDA UDI a7583131-8a37-4cef-9e5e-0ecab077727c 36 fields · synced May 30, 2026