Home GUDID B201CGSM0 Clear Guide SteriMASK
Primary DI B201CGSM0
Brand Clear Guide SteriMASK
Company CLEAR GUIDE MEDICAL, INC.
Model CGSM
Device description The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name PUI Drape, Surgical, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PUI Drape, Surgical, Exempt General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B201CGSM1 Package HIBCC 20 In Commercial Distribution B201CGSM0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Intraoperative ultrasound imaging transducer cover A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.
Regulatory Flags# DUNS number 965399905 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B201CGOH0 Clear Guide Optical Head CGOH CG-OH 2016-09-21 B201CGTT0 Clear Guide TipTAG CGTT 2017-04-07 B201CGVM0 Clear Guide VisiMARKER CGVM 2016-09-21 B201CGCORE170 Clear Guide CORE CGCORE17 CG-CORE17 2022-10-07 B201CGCORE240 Clear Guide CORE CGCORE24 CG-CORE24 2022-10-07 B201CGOHM0 Clear Guide Optical Head CGOHM CG-OH-M 2022-10-07 B201CGCORE130 Clear Guide CORE CGCORE13 CG-CORE-13 2022-10-06 B201CGCORE24MR0 Clear Guide CORE CGCORE24MR CG-CORE24-MR 2022-10-06 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 B201CGSG140 Clear Guide SteriGRID CGSG14 CG-SG14 2026-05-11 B201CGSG0 Clear Guide SteriGRID CGSG CG-SG 2025-01-10 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 B201CGSMM0 Clear Guide SteriMASK CGSMM CG-SM-M 2022-10-03 B201CGSCENERGY0 Clear Guide SCENERGY CGSCENERGY 2016-09-21 B201CGONE0 Clear Guide ONE CGONE 2016-09-21
Other Devices Sharing Product Codes# 
clearguidemedical.com