Arctic Front Advance Pro™

GUDID 00763000245436

CATH AFAPRO28 AFA PRO 28 US

MEDTRONIC, INC.

Cardiac cryosurgical system catheter

• Primary Device ID: 00763000245436
• NIH Device Record Key: 40acd384-c33e-4001-9916-03d0c8f3f29a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arctic Front Advance Pro™
• Version Model Number: AFAPRO28
• 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

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000245436 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [Arctic Front Advance Pro™]

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• 00763000245436: CATH AFAPRO28 AFA PRO 28 US
• 00763000245412: CATH AFAPRO23 AFA PRO 23 US
• 00763000341503: CATH AFAPRO28 AFA PRO 28 US MVC
• 00763000341497: CATH AFAPRO23 AFA PRO 23 US MVC
• 00763000431464: CATH AFAPRO28 AFA PRO 28 US
• 00763000431457: CATH AFAPRO23 AFA PRO 23 US PB
• 00763000707781: CATH AFAPRO28 AFA PRO 28 US MVC
• 00763000707774: CATH AFAPRO23 AFA PRO 23 US MVC