Freezor® Xtra

GUDID 00643169672482

CATHETER 227F5 FREEZOR XTRA5 LG 7F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter

• Primary Device ID: 00643169672482
• NIH Device Record Key: feb33e20-6372-48f2-bb7a-4b5cb70b9c2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freezor® Xtra
• Version Model Number: 227F5
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169672482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020045

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

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: 2017-02-16

On-Brand Devices [Freezor® Xtra]

• 00613994610829: CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F
• 00613994610812: CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
• 00613994610805: CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
• 00643169023536: CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F
• 00643169023529: CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
• 00643169023512: CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
• 00643169672482: CATHETER 227F5 FREEZOR XTRA5 LG 7F
• 00643169672475: CATHETER 227F3 FREEZOR XTRA3 MED7F
• 00643169672468: CATHETER 227F1 FREEZOR XTRA1 SH 7F
• 00643169504950: CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F
• 00643169504943: CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
• 00643169504936: CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
• 00643169450349: CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
• 00643169450332: CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
• 00643169450325: CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F