Identity
- Trade Name
- XVS C Headset IPD-60 LCD Display FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Model / Reference
- AHMD601CLD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290113781252 FDA UDI
- 510(k) Number
- K250255 FDA UDI
- FDA Product Code
- SBF 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
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: Multi-purpose stereotactic surgery system
XVS C Headset IPD-60 LCD Display by Augmedics Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K250255 also covers:
- Arc Clamp — AUGMEDICS LTD.
- C-arm Ring Adaptor — AUGMEDICS LTD.
- PC Mouse — AUGMEDICS LTD.
- Patient Marker Extender — AUGMEDICS LTD.
- Perc Pin Adaptor — AUGMEDICS LTD.
- Standard perc pin tray, instruments included — AUGMEDICS LTD.
- Standard xvision tray, instruments included — AUGMEDICS LTD.
- Straight Clamp — AUGMEDICS LTD.
- Tall Straight Clamp — AUGMEDICS LTD.
- XVS C Headset IPD-60 Clear Display — AUGMEDICS LTD.
- XVS C Headset IPD-64 Clear Display — AUGMEDICS LTD.
- XVS C Headset IPD-64 LCD Display — 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 281dec55-4c91-4675-b1a0-461598162be4 33 fields · synced Jun 1, 2026