Clear Guide VisiMARKER II Non-Sterile CG-VM2-NS

GUDID B201CGVM2NS0

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.

CLEAR GUIDE MEDICAL, INC.

Imaging lesion localization marker, external, single-use
Primary Device IDB201CGVM2NS0
NIH Device Record Key9c067566-c982-473b-b590-e097764b4261
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear Guide VisiMARKER II Non-Sterile
Version Model NumberCGVM2NS
Catalog NumberCG-VM2-NS
Company DUNS965399905
Company NameCLEAR GUIDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB201CGVM2NS0 [Primary]
HIBCCB201CGVM2NS1 [Package]
Package: Shelf Box [15 Units]
In Commercial Distribution
HIBCCB201CGVM2NS2 [Package]
Contains: B201CGVM2NS1
Package: Shipper Box [16 Units]
In Commercial Distribution
HIBCCB201CGVM2NS3 [Package]
Contains: B201CGVM2NS1
Package: Mailer Box [1 Units]
In Commercial Distribution

FDA Product Code

JACSystem, X-Ray, Film Marking, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-12
Device Publish Date2022-10-04

Devices Manufactured by CLEAR GUIDE MEDICAL, INC.

B201CGCORE170 - Clear Guide CORE2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
B201CGCORE240 - Clear Guide CORE2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
B201CGOHM0 - Clear Guide Optical Head2022-10-17 The device is intended as an accessory hardware to provide input into medical device software by capturing video and other senso
B201CGCORE130 - Clear Guide CORE2022-10-14 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
B201CGCORE24MR0 - Clear Guide CORE2022-10-14 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
B201CGVM20 - Clear Guide VisiMARKER II2022-10-12 The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a pat
B201CGVM2NS0 - Clear Guide VisiMARKER II Non-Sterile2022-10-12The 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.
B201CGVM2NS0 - Clear Guide VisiMARKER II Non-Sterile2022-10-12 The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a pat
B201CGVMNS0 - Clear Guide VisiMARKER Non-Sterile2022-10-12 The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a pat

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