Torqr™

GUDID 00763000227449

CATH 041010JM TORQR W/O CE

MEDTRONIC, INC.

Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use
Primary Device ID00763000227449
NIH Device Record Key2b33b8c9-6bc0-4d93-839f-66f12ae9d6b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorqr™
Version Model Number041010JM
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]
GS100763000227449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Torqr™]

00763000227524CATH 04122JM TORQR W/O CE
00763000227517CATH 04122UM TORQR W/O CE
00763000227500CATH 04125JM TORQR W/O CE
00763000227494CATH 04125UM TORQR W/O CE
00763000227487CATH 04130DS TORQR W/O CE
00763000227470CATH 041005DM TORQR W/O CE
00763000227463CATH 041005JM TORQR W/O CE
00763000227456CATH 041005UM TORQR W/O CE
00763000227449CATH 041010JM TORQR W/O CE
00763000227432CATH 041010UM TORQR W/O CE
00763000227425CATH 041002JM TORQR W/O CE
00763000227418CATH 041002UM TORQR W/O CE
00763000227401CATH 041565CS TORQR CS W/O CE
00763000227395CATH 041590CS TORQR CS W/O CE
00763000227388CATH 041865CS TORQR CS W/O CE
00763000227371CATH 041890CS TORQR CS W/O CE

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