Identity
- Trade Name
- Endo Carry-On Procedure Kit FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- Endo Carry-On Procedure Kit FDA UDI
- Model / Reference
- CPK-358000-0002 FDA UDI
- Description
- Endo Carry-On Procedure Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00677964108051 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
- Not 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
A comprehensive Endo Carry-On Procedure Kit, designed for the preparation of endoscopy procedures in patients. This device supports various tasks and is intended to be used one-time only.
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
- Medivators Inc.
Sources (1)
- FDA UDI 25b3bd01-3de4-4930-8ed1-0df104ae78a5 35 fields · synced Jul 8, 2026