ACTIVA RC

GUDID 00643169529779

INS 37612 ACTIVA RC NO PARYLENE PAPR MAN

MEDTRONIC, INC.

Deep brain electrical stimulation system
Primary Device ID00643169529779
NIH Device Record Keybaec76c3-27a8-446f-9e2c-cb1772441908
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTIVA RC
Version Model Number37612
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169529779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

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 Date2015-06-01

On-Brand Devices [ACTIVA RC]

00643169529779INS 37612 ACTIVA RC NO PARYLENE PAPR MAN
00643169529762INS 37612 ACTIVA RC NO PARYLENE EMANUAL

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