Clear Guide ONE

GUDID B201CGONE1

CLEAR GUIDE MEDICAL, INC.

Ultrasound imaging system application software
Primary Device IDB201CGONE1
NIH Device Record Key7714baa1-8e3b-429d-9468-f1a8523c945b
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear Guide ONE
Version Model NumberCGONE
Company DUNS965399905
Company NameCLEAR GUIDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB201CGONE0 [Primary]
HIBCCB201CGONE1 [Package]
Contains: B201CGONE0
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

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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