Identity
- Trade Name
- Trial Procedure Kit FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Device Name
- Trial Procedure Kit FDA UDI
- Model / Reference
- CPKT-430500-0001 FDA UDI
- Description
- Trial Procedure Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00677964093463 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
Trial Procedure Kit by Medivators Inc. — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medivators Inc.
Sources (1)
- FDA UDI 3f9ff35b-cd98-4fd9-8938-471e4af050d2 35 fields · synced Jun 6, 2026