Clear Guide TipTAG

Primary DI
B201CGTT1
Brand
Clear Guide TipTAG
Company
CLEAR GUIDE MEDICAL, INC.
Model
CGTT
Published
2017-04-07
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
CodeName
JACSystem, X-Ray, Film Marking, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JACSystem, X-Ray, Film Marking, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B201CGTT1PackageHIBCC10In Commercial Distribution
B201CGTT2PackageHIBCC4In Commercial Distribution
B201CGTT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, external, single-useA 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.

Sterilization Methods#

Method table
Method

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 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
B201CGSM0Clear Guide SteriMASKCGSM2016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30815112021505E-Z-MarkBracco Diagnostics Inc.JAC2026-01-09
00816589021219Fiducial Marker, SterileMONTERIS MEDICAL INCJAC2025-02-07
B201CGPAT0Clear Guide TP Access ToolCLEAR GUIDE MEDICAL, INC.JAC2025-01-10
B201CGTPF0Clear Guide TP Access FrameCLEAR GUIDE MEDICAL, INC.JAC2025-01-10
00815137022265RT-SPOTBeekley CorporationJAC2024-08-29
00815137022272RT-SPOTBeekley CorporationJAC2024-08-29
00815137022289RT-SPOTBeekley CorporationJAC2024-08-29
00815137022296RT-SPOTBeekley CorporationJAC2024-08-29
00815137022302RT-SPOTBeekley CorporationJAC2024-08-29
00815137022258RT-SPOTBeekley CorporationJAC2024-08-29
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10815137022279RT-SPOTBeekley CorporationJAC2024-08-29
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B971RTD12L0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTC121SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12L1SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S1SuremarkJessop Precision Products Inc.JAC2024-02-01
03701313007942K-BALLS.M.A.I.OJAC2023-12-22
03613720287971UNiDâ„¢ Calibration SphereMEDTRONIC SOFAMOR DANEK, INC.JAC2023-08-20
B971RTC1000SuremarkJessop Precision Products Inc.JAC2023-01-16
B971RTL100SuremarkJessop Precision Products Inc.JAC2023-01-16
00815137022166R-SPOTBeekley CorporationJAC2023-01-09
00815137022173L-SPOTBeekley CorporationJAC2023-01-09
10815137022163R-SPOTBeekley CorporationJAC2023-01-09
10815137022170L-SPOTBeekley CorporationJAC2023-01-09
B201CGVM20Clear Guide VisiMARKER IICLEAR GUIDE MEDICAL, INC.JAC2022-10-04
B201CGVM2NS0Clear Guide VisiMARKER II Non-SterileCLEAR GUIDE MEDICAL, INC.JAC2022-10-04