Xvs Markers With C-Link Kit 10 Sets Pack

FDA UDI

Class II (US FDA UDI)

by Augmedics Ltd.

Identity

Trade Name: XVS MARKERS WITH C-LINK KIT 10 SETS PACK FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Model / Reference: ASP07059 FDA UDI

Identifiers

Primary DI / UDI-DI: 17290113781044 FDA UDI
510(k) Number: K241481 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multi-purpose stereotactic surgery system

Xvs Markers With C-Link Kit 10 Sets Pack by Augmedics Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K241481 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: Augmedics Ltd.

Sources (1)

FDA UDI ed604207-3458-49ac-b2c1-f1d664e1c5bf 33 fields · synced May 30, 2026