Clear Guide TipTAG

GUDID B201CGTT1

CLEAR GUIDE MEDICAL, INC.

Imaging lesion localization marker, external, single-use
Primary Device IDB201CGTT1
NIH Device Record Key40bbefbb-6388-4fc4-9a01-2a5614400d52
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear Guide TipTAG
Version Model NumberCGTT
Company DUNS965399905
Company NameCLEAR GUIDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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
HIBCCB201CGTT0 [Primary]
HIBCCB201CGTT1 [Package]
Contains: B201CGTT0
Package: [10 Units]
In Commercial Distribution
HIBCCB201CGTT2 [Package]
Package: Shipper Box [4 Units]
In Commercial Distribution

FDA Product Code

JACSystem, X-Ray, Film Marking, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-07

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-Sterile2022-10-12 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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