GUDID 00643169183803

CABLE 671PCNA CRYOFLEX N.A. ONLY

MEDTRONIC, INC.

General cryosurgical system, cryogen gas, mechanical
Primary Device ID00643169183803
NIH Device Record Key69bbff05-7ada-413a-8d77-cb8733ae323a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number671PCNA
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169183803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCLSurgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-01

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