ACTIVA PC

GUDID 00643169529786

INS 37601 ACTIVA PC NO PARYLENE EMANUAL

MEDTRONIC, INC.

Deep brain electrical stimulation system
Primary Device ID00643169529786
NIH Device Record Key3b7beaaf-3d03-45d6-bc75-d03034999f3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTIVA PC
Version Model Number37601
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 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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 126 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169529786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MFRStimulator, brain, implanted, for behavior modification
MRUimplanted subcortical electrical Stimulator (motor disorders)

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 Date2015-01-30

On-Brand Devices [ACTIVA PC]

00643169529793INS 37601 ACTIVA PC NO PARYLENE PAPR MAN
00643169529786INS 37601 ACTIVA PC NO PARYLENE EMANUAL

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.