Identity
- Trade Name
- WatchTower FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Image Calibrator with Assembly Kit FDA UDI
- Model / Reference
- NAVTL0001 FDA UDI
- Description
- Image Calibrator with Assembly Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719876737281 FDA UDI
- 510(k) Number
- K220348 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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: Neurological stereotactic surgery system
WatchTower by Intai Technology Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220348 also covers:
- Anatase Spine Surgery Navigation System — Intai Technology Corporation
- Anatase Spine Surgery Navigation System — Intai Technology Corporation
- WatchTower — Intai Technology Corporation
- WatchTower — Intai Technology Corporation
- WatchTower — Intai Technology Corporation
- WatchTower — Intai Technology Corporation
- WatchTower — Intai Technology Corporation
- WatchTower — Intai Technology Corporation
- WatchTower — Intai Technology Corporation
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
- Intai Technology Corporation
Sources (1)
- FDA UDI 6ced63a3-9b13-461b-8bd0-dba280d5d40a 35 fields · synced May 30, 2026