Identity
- Trade Name
- 3NT Video Console FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes. FDA UDI
- Model / Reference
- CCU-0100 FDA UDI
- Description
- The 3NT Video Console is used to display the video image received from 3NT Medical endoscopes. FDA UDI
Identifiers
- Catalog Number
- CCU-0100 FDA UDI
- Primary DI / UDI-DI
- 07290016539097 FDA UDI
- 510(k) Number
- K192305 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic video image processing unit
3NT Video Console by 3nt Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192305 also covers:
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
- 3nt Medical , Ltd.
Sources (1)
- FDA UDI a3c61d29-6883-43f4-af81-16e600a5ec54 35 fields · synced Jun 8, 2026