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Clear Guide VisiMARKER II

FDA UDI

Class I (US FDA UDI)

by Clear Guide Medical

Identity

Trade Name
Clear Guide VisiMARKER II FDA UDI
Generic Name
Imaging lesion localization marker, external, single-use FDA UDI
Device Name
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. FDA UDI
Model / Reference
CGVM2 FDA UDI
Description
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. FDA UDI

Identifiers

Catalog Number
CG-VM2 FDA UDI
Primary DI / UDI-DI
B201CGVM20 FDA UDI
FDA Product Code
JAC FDA UDI
GMDN Term
Imaging lesion localization marker, external, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Imaging lesion localization marker, external, single-use

Clear Guide VisiMARKER II by Clear Guide Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Imaging lesion localization marker, external, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clear Guide Medical

Sources (1)

  • FDA UDI 0e30e459-00d7-40b3-80fa-19bc41b33433 35 fields · synced Jun 9, 2026