Identity
- Trade Name
- Zutron Medical FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- Endoscopy Combo Kit with Valve Basket (WWE)-Basin, Gauze, Sponges, Port Cover, Valve Bag, Channel Brush, Suction Tubing FDA UDI
- Model / Reference
- Endoscopy Procedure Kit FDA UDI
- Description
- Endoscopy Combo Kit with Valve Basket (WWE)-Basin, Gauze, Sponges, Port Cover, Valve Bag, Channel Brush, Suction Tubing FDA UDI
Identifiers
- Catalog Number
- ZUTR40008 FDA UDI
- Primary DI / UDI-DI
- 00817658020133 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 eac2dcd6-7bdc-49d6-a42d-508658bd7fc3 36 fields · synced May 30, 2026