Arctic Front®

GUDID 00643169073265

CATHETER 2AF282 ARCTIC FRONT 28MM BLUE

MEDTRONIC, INC.

Cardiac cryosurgical system catheter

• Primary Device ID: 00643169073265
• NIH Device Record Key: 23313685-e6e2-40b0-9a3a-ffa82f70dc0c
• Commercial Distribution Discontinuation: 2018-06-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Arctic Front®
• Version Model Number: 2AF282
• 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

• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter
• Length: 100 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169073265 [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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [Arctic Front®]

• 00643169105539: CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
• 00643169105515: CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
• 00643169073265: CATHETER 2AF282 ARCTIC FRONT 28MM BLUE
• 00643169073258: CATHETER 2AF232 ARCTIC FRONT 23MM RED
• 00643169007581: CATHETER 2AF282 ARCTIC FRONT 28MM BLUE
• 00643169007574: CATHETER 2AF232 ARCTIC FRONT 23MM RED
• 00643169504837: CATHETER 2AF234 ARCTIC FRONT ADV US 23MM