Clear Guide SteriMASK CG-SM-M

GUDID B201CGSMM0

The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet.

CLEAR GUIDE MEDICAL, INC.

Optical medical device procedural cover

• Primary Device ID: B201CGSMM0
• NIH Device Record Key: 33153273-0df7-402e-b320-5cfb1b2f138a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Guide SteriMASK
• Version Model Number: CGSMM
• Catalog Number: CG-SM-M
• 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: true
• 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

Customer Support Contacts

• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com
• Phone: +1 (443) 267-7661
• Email: support@clearguidemedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B201CGSMM0 [Primary]
HIBCC	B201CGSMM1 [Package]; Package: Box [20 Units]; In Commercial Distribution
HIBCC	B201CGSMM2 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-11
• Device Publish Date: 2022-10-03

On-Brand Devices [Clear Guide SteriMASK]

• B201CGSM1: CGSM
• B201CGSMM0: The device is a sterile accessory intended to provide a sterile barrier for medical procedures t