GUDID 10681490164594

ACC 7440 ISTIM PROG ANT23.0LG

MEDTRONIC, INC.

Multiple active implantable device programmer
Primary Device ID10681490164594
NIH Device Record Keyd1649ce7-6462-48f7-9ef6-dd6ec2d35482
Commercial Distribution Discontinuation2018-08-13
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number7440
Company DUNS796986144
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 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

Device Dimensions

Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter
Length23 Inch
Length58 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110681490164594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-07-07
Device Publish Date2014-09-23

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