DBS™ Reclaim®

GUDID 00643169864283

LEAD 3391S-40 NO OR CBL MRI COND EMN ALP

MEDTRONIC, INC.

Deep brain electrical stimulation system
Primary Device ID00643169864283
NIH Device Record Key4d1df324-b561-446a-8f90-4d35a0343de1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBS™ Reclaim®
Version Model Number3391S-40
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Length40 Centimeter
Length40 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169864283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2018-02-24

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