Identity
- Trade Name
- OLYMPUS ENDOSCOPY KIT IV FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- OLYMPUS ENDOSCOPY KIT IV FDA UDI
- Model / Reference
- 345CKETD FDA UDI
- Description
- OLYMPUS ENDOSCOPY KIT IV FDA UDI
Identifiers
- Catalog Number
- 345CKETD FDA UDI
- Primary DI / UDI-DI
- 00810929044661 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Endoscopy preparation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopy preparation kit
Olympus Endoscopy Kit Iv by Ruhof Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopy preparation kit.
- Endo Carry-On Procedure Kit — MEDIVATORS INC. · Class II
- Custom Procedure Kit — MEDIVATORS INC. · Class II
- Compliance EndoKit™ — Boston Scientific · Class I
- Endo-Carry-on Procedure Kit — MEDIVATORS INC. · Class II
- Custom Procedure Kit — MEDIVATORS INC. · Class II
- Compliance EndoKit™ — Boston Scientific · Class I
- Endo Carry-on Procedure Kit — MEDIVATORS INC. · Class II
- VIA — US Endoscopy · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ruhof Corporation
Sources (1)
- FDA UDI bc031891-e188-405f-a30f-3a706663181d 34 fields · synced May 31, 2026