Identity
- Trade Name
- Control unit FDA UDI
- Generic Name
- Optical surgical navigation device tracking system FDA UDI
- Device Name
- Control unit FDA UDI
- Model / Reference
- NS002 FDA UDI
- Description
- Control unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640176970023 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Optical surgical navigation device tracking 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Optical surgical navigation device tracking system
Control unit by Naviswiss AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193094 also covers:
- Acetabular Adapter P — Naviswiss AG
- Articulated Arm — Naviswiss AG
- Calibration bar — Naviswiss AG
- Cortical bone screw — Naviswiss AG
- Cortical bone screw (self drilling, 3.5 x 23 mm, wear part) — Naviswiss AG
- Cross coupling adapter — Naviswiss AG
- Cup impactor adapter B — Naviswiss AG
- Cutting block (1.27mm, adjustable) — Naviswiss AG
- Femur base (adjustable) — Naviswiss AG
- Femur base handle — Naviswiss AG
- Fixation plate — Naviswiss AG
- Fixation plate inserter — Naviswiss AG
K223351 also covers:
- Acetabular Adapter P — Naviswiss AG
- Articulated Arm — Naviswiss AG
- Calibration bar — Naviswiss AG
- Cortical bone screw — Naviswiss AG
- Cortical bone screw (self drilling, 3.5 x 23 mm, wear part) — Naviswiss AG
- Cross coupling adapter — Naviswiss AG
- Cup impactor adapter B — Naviswiss AG
- Cutting block (1.27mm, adjustable) — Naviswiss AG
- Femur base (adjustable) — Naviswiss AG
- Femur base handle — Naviswiss AG
- Fixation plate — Naviswiss AG
- Fixation plate inserter — Naviswiss AG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Naviswiss AG
Sources (1)
- FDA UDI e4ea28ef-7a3c-4f02-8d17-5d8aa25efa16 34 fields · synced May 30, 2026