Clear Guide VisiMARKER Non-Sterile CG-VM-NS

GUDID B201CGVMNS0

The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

CLEAR GUIDE MEDICAL, INC.

Imaging lesion localization marker, external, single-use

• Primary Device ID: B201CGVMNS0
• NIH Device Record Key: d234869b-9308-45d6-8e69-bcbc07f28bc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Guide VisiMARKER Non-Sterile
• Version Model Number: CGVMNS
• Catalog Number: CG-VM-NS
• Company DUNS: 965399905
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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	B201CGVMNS0 [Primary]
HIBCC	B201CGVMNS1 [Package]; Package: Shelf Box [25 Units]; In Commercial Distribution
HIBCC	B201CGVMNS2 [Package]; Contains: B201CGVMNS1; Package: Shipper Box [16 Units]; In Commercial Distribution
HIBCC	B201CGVMNS3 [Package]; Contains: B201CGVMNS1; 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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-12
• Device Publish Date: 2022-10-04

Devices Manufactured by CLEAR GUIDE MEDICAL, INC.

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• B201CGSCENERGYTP0 - Clear Guide SCENERGY TP: 2025-01-20 The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and
• B201CGSG0 - Clear Guide SteriGRID: 2025-01-20 The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements d
• B201CGTPF0 - Clear Guide TP Access Frame: 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima
• B201CGTPP0 - Clear Guide TP Access Posts: 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima
• 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