DBS ™

GUDID 00643169313552

LEAD 3391S-40 PSYCH DBS OCD HDE EMAN

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead
Primary Device ID00643169313552
NIH Device Record Key598fd628-d971-4067-b542-3321d6ac1af0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBS ™
Version Model Number3391S-40
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 Kittrue
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
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

Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
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
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
GS100643169313552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MFRStimulator, brain, implanted, for behavior modification
OLMDeep brain stimulator for obsessive compulsive disorder (OCD)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [DBS ™]

00643169313552LEAD 3391S-40 PSYCH DBS OCD HDE EMAN
00643169313538LEAD 3389S-40 DBS ACTIVA STIMLOC LEADCAP
00643169313514LEAD 3387S-40 DBS ACTIVA STMLC LCAP EMAN
00643169313491LEAD 3387S-40 DBS ACTIVA STIMLOC LEADCAP

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