GUDID 00643169183803

CABLE 671PCNA CRYOFLEX N.A. ONLY

MEDTRONIC, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00643169183803
• NIH Device Record Key: 69bbff05-7ada-413a-8d77-cb8733ae323a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 671PCNA
• 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: false
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169183803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121878

FDA Product Code

• OCL: Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-01

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