Clear Guide SCENERGY

GUDID B201CGSCENERGY1

CLEAR GUIDE MEDICAL, INC.

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• Primary Device ID: B201CGSCENERGY1
• NIH Device Record Key: 4b8736c5-2180-4cc9-a0a5-2e3ac0689678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Guide SCENERGY
• Version Model Number: CGSCENERGY
• Company DUNS: 965399905
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	B201CGSCENERGY0 [Primary]
HIBCC	B201CGSCENERGY1 [Package]; Contains: B201CGSCENERGY0; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153004

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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