Sentinel CMS15-10C-US

GUDID 00863229000004

CLARET MEDICAL, INC.

Embolic protection filtering guidewire

• Primary Device ID: 00863229000004
• NIH Device Record Key: 4664332e-d3a5-4ed8-ba46-c4944559effb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentinel
• Version Model Number: CMS15-10C-US
• Catalog Number: CMS15-10C-US
• Company DUNS: 020980677
• Company Name: CLARET 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 7075289300
• Email: quality@claretmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863229000004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160043

FDA Product Code

• PUM: Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-16
• Device Publish Date: 2018-06-12