St. Jude Medical Infinity™ 6371

GUDID 05415067030344

8CH Flex Extn, 50 cm

ST. JUDE MEDICAL, INC.

Deep brain electrical stimulation system
Primary Device ID05415067030344
NIH Device Record Key71024140-66a7-4ce4-b730-b61ca2dcd80a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSt. Jude Medical Infinity™
Version Model NumberDBS System
Catalog Number6371
Company DUNS149818952
Company NameST. JUDE MEDICAL, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067030344 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-23

On-Brand Devices [St. Jude Medical Infinity™]

054150670303518CH Flex Extn, 60 cm
054150670303448CH Flex Extn, 50 cm
054150670303378CH Directional Lead, 40 cm, 1.5
054150670303208CH Directional Lead, 40 cm, 0.5
054150670303138CH Directional Lead, 30 cm, 1.5
054150670303068CH Directional Lead, 30 cm, 0.5
054150670208648CH Flex Extn, 90 cm
054150670208578CH Flex Extn, 60 cm
054150670207038CH Directional Lead, 40 cm, 1.5
054150670206978CH Directional Lead, 40 cm, 1.5
054150670206808CH Directional Lead, 40 cm, 0.5
054150670206738CH Directional Lead, 40 cm, 0.5
054150670206668CH Directional Lead, 30 cm, 1.5
054150670206598CH Directional Lead, 30 cm, 1.5
054150670206428CH Directional Lead, 30 cm, 0.5
054150670206358CH Directional Lead, 30 cm, 0.5
054150670203078CH Flex Extn, 50 cm

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