Home GUDID B201CGVM2 Clear Guide VisiMARKER
Primary DI B201CGVM2
Brand Clear Guide VisiMARKER
Company CLEAR GUIDE MEDICAL, INC.
Model CGVM
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name JAC System, X-Ray, Film Marking, Radiographic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JAC System, X-Ray, Film Marking, Radiographic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B201CGVM1 Package HIBCC 25 In Commercial Distribution B201CGVM2 Package HIBCC 16 In Commercial Distribution B201CGVM3 Package HIBCC 1 In Commercial Distribution B201CGVM0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Imaging lesion localization marker, external, single-use A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.
Regulatory Flags# DUNS number 965399905 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B201CGSG140 Clear Guide SteriGRID CGSG14 CG-SG14 2026-05-11 B201CGTT0 Clear Guide TipTAG CGTT 2017-04-07 B201CGVM0 Clear Guide VisiMARKER CGVM 2016-09-21 B201CGSG0 Clear Guide SteriGRID CGSG CG-SG 2025-01-10 B201CGVM20 Clear Guide VisiMARKER II CGVM2 CG-VM2 2022-10-04 B201CGVM2NS0 Clear Guide VisiMARKER II Non-Sterile CGVM2NS CG-VM2-NS 2022-10-04 B201CGVMNS0 Clear Guide VisiMARKER Non-Sterile CGVMNS CG-VM-NS 2022-10-04 B201CGOH0 Clear Guide Optical Head CGOH CG-OH 2016-09-21 B201CGOHM0 Clear Guide Optical Head CGOHM CG-OH-M 2022-10-07 B201CGPAT0 Clear Guide TP Access Tool CGPAT CG-PAT 2025-01-10 B201CGSCENERGYTP0 Clear Guide SCENERGY TP CGSCENERGYTP CG-SCENERGY-TP 2025-01-10 B201CGTPF0 Clear Guide TP Access Frame CGTPF CG-TPF 2025-01-10 B201CGTPP0 Clear Guide TP Access Posts CGTPP CG-TPP 2025-01-10 B201CGCORE130 Clear Guide CORE CGCORE13 CG-CORE-13 2022-10-06 B201CGCORE170 Clear Guide CORE CGCORE17 CG-CORE17 2022-10-07 B201CGCORE240 Clear Guide CORE CGCORE24 CG-CORE24 2022-10-07 B201CGCORE24MR0 Clear Guide CORE CGCORE24MR CG-CORE24-MR 2022-10-06 B201CGSMM0 Clear Guide SteriMASK CGSMM CG-SM-M 2022-10-03 B201CGSCENERGY0 Clear Guide SCENERGY CGSCENERGY 2016-09-21 B201CGSM0 Clear Guide SteriMASK CGSM 2016-09-21
Other Devices Sharing Product Codes#