Clear Guide SteriMASK

GUDID B201CGSM1

CLEAR GUIDE MEDICAL, INC.

Intraoperative ultrasound imaging transducer cover

• Primary Device ID: B201CGSM1
• NIH Device Record Key: 9b09e593-be27-487c-914a-9f314dfe8a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Guide SteriMASK
• Version Model Number: CGSM
• 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: true
• 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
• 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	B201CGSM0 [Primary]
HIBCC	B201CGSM1 [Package]; Contains: B201CGSM0; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• KKX: Drape, Surgical
• PUI: Drape, Surgical, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-23
• Device Publish Date: 2016-09-21

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