Identity
- Trade Name
- XVS Headset Battery Charger FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Model / Reference
- APWR0004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290113780309 FDA UDI
- 510(k) Number
- K190929 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Multi-purpose 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
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
Yes
FDA UDI
Category: Multi-purpose stereotactic surgery system
XVS Headset Battery Charger by Augmedics Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190929 also covers:
- All-in-one computer + Pre-installed Software — AUGMEDICS LTD.
- Clamp Removal Tool — AUGMEDICS LTD.
- Ergonomic Navigated Tool Adaptor — AUGMEDICS LTD.
- Fixed 3-4mm Universal tool Adapter Leg Down — AUGMEDICS LTD.
- Fixed 3-4mm Universal tool Adapter Leg Up — AUGMEDICS LTD.
- Navigated Tool Adaptor — AUGMEDICS LTD.
- Roll stand — AUGMEDICS LTD.
- Screwdriver 4MM — AUGMEDICS LTD.
- Swivel 4-5 mm universal tool adapter Leg down — AUGMEDICS LTD.
- Swivel 4-5 mm universal tool adapter Leg up — AUGMEDICS LTD.
- Swivel 5-6 mm universal tool adapter leg up — AUGMEDICS LTD.
- Swivel 5-6 mm universal tool adapter leg up — AUGMEDICS LTD.
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
- Augmedics Ltd.
Sources (1)
- FDA UDI 7f8fc70f-a7c1-47e7-a4c7-c3e27f88e0d3 33 fields · synced May 30, 2026