GUDID 00643169449152

EXT 3708660 DBS NEW BOOT US SYM MRI

MEDTRONIC, INC.

Deep brain electrical stimulation system
Primary Device ID00643169449152
NIH Device Record Key94da7390-561e-40c1-b446-9e4ff41b670f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3708660
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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

Length60 Centimeter
Length60 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -29 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment TemperatureBetween -29 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169449152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-09-18

Devices Manufactured by MEDTRONIC, INC.

00199150050161 - NA2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
00199150050178 - NA2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E
00199150050185 - NA2025-09-29 CUSTOM PACK BB4Q12R27 UNIV H/L
20199150050202 - NA2025-09-29 CUSTOM PACK BB12P63R 4PK GPS TABLE PK
00199150050871 - NA2025-09-29 CUSTOM PACK BB11R66R2 TBL 1/4
00763000877033 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15006X SPR LEG RX US M
00763000877040 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15010X SPR LEG RX US M
00763000877057 - SPRINTER® LEGEND2025-09-29 BALLOON SPL15012X SPR LEG RX US M

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.