FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B201CGSM1PackageHIBCC20In Commercial Distribution
B201CGSM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative ultrasound imaging transducer coverA 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.

Contacts#

Phone, Email table
PhoneEmail
+1 (443) 267-7661support@clearguidemedical.com

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 DIBrandModelCatalogPublished
B201CGSG140Clear Guide SteriGRIDCGSG14CG-SG142026-05-11
B201CGTT0Clear Guide TipTAGCGTT2017-04-07
B201CGVM0Clear Guide VisiMARKERCGVM2016-09-21
B201CGSG0Clear Guide SteriGRIDCGSGCG-SG2025-01-10
B201CGVM20Clear Guide VisiMARKER IICGVM2CG-VM22022-10-04
B201CGVM2NS0Clear Guide VisiMARKER II Non-SterileCGVM2NSCG-VM2-NS2022-10-04
B201CGVMNS0Clear Guide VisiMARKER Non-SterileCGVMNSCG-VM-NS2022-10-04
B201CGOH0Clear Guide Optical HeadCGOHCG-OH2016-09-21
B201CGOHM0Clear Guide Optical HeadCGOHMCG-OH-M2022-10-07
B201CGPAT0Clear Guide TP Access ToolCGPATCG-PAT2025-01-10
B201CGSCENERGYTP0Clear Guide SCENERGY TPCGSCENERGYTPCG-SCENERGY-TP2025-01-10
B201CGTPF0Clear Guide TP Access FrameCGTPFCG-TPF2025-01-10
B201CGTPP0Clear Guide TP Access PostsCGTPPCG-TPP2025-01-10
B201CGCORE130Clear Guide CORECGCORE13CG-CORE-132022-10-06
B201CGCORE170Clear Guide CORECGCORE17CG-CORE172022-10-07
B201CGCORE240Clear Guide CORECGCORE24CG-CORE242022-10-07
B201CGCORE24MR0Clear Guide CORECGCORE24MRCG-CORE24-MR2022-10-06
B201CGSMM0Clear Guide SteriMASKCGSMMCG-SM-M2022-10-03
B201CGSCENERGY0Clear Guide SCENERGYCGSCENERGY2016-09-21
B201CGONE0Clear Guide ONECGONE2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10192253066586CONVERTORSCardinal Health 200, LLCPUI2025-11-07
10192253066531CONVERTORSCardinal Health 200, LLCPUI2025-09-24
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10192253066494CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066500CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066517CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066524CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066548CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066555CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066562CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066579CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066593CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066609CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066616CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066623CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066654CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066692CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253066708CONVERTORSCardinal Health 200, LLCPUI2025-06-18
10192253050233CONVERTORSCardinal Health 200, LLCPUI2024-09-10
10192253050240CONVERTORSCardinal Health 200, LLCPUI2024-09-10
10080196073351MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-24
10080196739240MedlineMEDLINE INDUSTRIES, INC.PUI2023-10-12
10080196313846MedlineMEDLINE INDUSTRIES, INC.PUI2023-06-08
10080196744626MedlineMEDLINE INDUSTRIES, INC.PUI2023-06-08
10080196283248MedlineMEDLINE INDUSTRIES, INC.PUI2023-01-06
10080196746842MedlineMEDLINE INDUSTRIES, INC.PUI2023-01-06