Identity
- Trade Name
- Zutron Medical FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- Endoscopy Procedure Kit-Basin, Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Basin Lid, Transport Tote, Suction Tubing with Scallop Connectors, Valve Net, Scope Tip Protector, Scope Tag, Valve Brush, Channel Cleaning Brush, Vent Bag FDA UDI
- Model / Reference
- Endoscopy Procedure Kit FDA UDI
- Description
- Endoscopy Procedure Kit-Basin, Check Valve, Biopsy Valve, Gauze, Sponges, Lube, Basin Lid, Transport Tote, Suction Tubing with Scallop Connectors, Valve Net, Scope Tip Protector, Scope Tag, Valve Brush, Channel Cleaning Brush, Vent Bag FDA UDI
Identifiers
- Catalog Number
- ZUTR40112 FDA UDI
- Primary DI / UDI-DI
- 00817658023226 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 5faab909-fb57-45fc-a46e-343088e9daa2 36 fields · synced Jun 1, 2026