MO.MA ULTRA

GUDID 08033477071909

CATH MUS0130069X6 CPD ULTRA US 9F UL950

MEDTRONIC, INC.

Carotid artery embolic protection system

• Primary Device ID: 08033477071909
• NIH Device Record Key: 9e228865-f9d6-4d57-ad7c-0d7d59bda379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MO.MA ULTRA
• Version Model Number: MUS0130069X6
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033477071909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092177

FDA Product Code

• NTE: Temporary Carotid Catheter for Embolic Capture

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: 2019-04-09
• Device Publish Date: 2018-05-12

On-Brand Devices [MO.MA ULTRA]

• 08033477071909: CATH MUS0130069X6 CPD ULTRA US 9F UL950
• 08033477050140: Cath MUS0130069X6 CPD Ultra US 9F UL950
• 08033477090719: CATH MUS0130069X6 CPD ULTRA US 9F UL950