Clear Guide VisiMARKER

GUDID B201CGVM2

CLEAR GUIDE MEDICAL, INC.

Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use

• Primary Device ID: B201CGVM2
• NIH Device Record Key: 05984e54-aa8d-44d7-9917-16f29e88f934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Guide VisiMARKER
• Version Model Number: CGVM
• Company DUNS: 965399905
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B201CGVM0 [Primary]
HIBCC	B201CGVM1 [Package]; Contains: B201CGVM0; Package: [25 Units]; In Commercial Distribution
HIBCC	B201CGVM2 [Package]; Contains: B201CGVM1; Package: [16 Units]; In Commercial Distribution
HIBCC	B201CGVM3 [Package]; Contains: B201CGVM1; Package: Mailer Box [1 Units]; In Commercial Distribution

FDA Product Code

• JAC: System, X-Ray, Film Marking, Radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

Devices Manufactured by CLEAR GUIDE MEDICAL, INC.

• B201CGCORE170 - Clear Guide CORE: 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
• B201CGCORE240 - Clear Guide CORE: 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
• B201CGOHM0 - Clear Guide Optical Head: 2022-10-17 The device is intended as an accessory hardware to provide input into medical device software by capturing video and other senso
• B201CGCORE130 - Clear Guide CORE: 2022-10-14 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
• B201CGCORE24MR0 - Clear Guide CORE: 2022-10-14 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G
• B201CGVM20 - Clear Guide VisiMARKER II: 2022-10-12 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-Sterile: 2022-10-12 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-Sterile: 2022-10-12 The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a pat