Arctic Front Advance® ST

GUDID 00643169577732

CATHETER 2AFAST23 AF ADVANCE ST 23MM US

MEDTRONIC, INC.

Cardiac cryosurgical system catheter

• Primary Device ID: 00643169577732
• NIH Device Record Key: 87db8630-79a8-427e-8cff-ac6e8ad95286
• Commercial Distribution Discontinuation: 2016-10-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Arctic Front Advance® ST
• Version Model Number: 2AFAST23
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.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

Operating and Storage Conditions

• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between -31 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169577732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100010

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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: 2018-07-06
• Device Publish Date: 2015-05-28

On-Brand Devices [Arctic Front Advance® ST]

• 00643169577749: CATHETER 2AFAST28 AF ADVANCE ST 28MM US
• 00643169577732: CATHETER 2AFAST23 AF ADVANCE ST 23MM US