PISCES-QUAD PLUS™

GUDID 00613994722089

LEAD 3888-56 PISCES QD 12MM SP US EMANUA

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead Neural-tissue electrical stimulation lead Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Primary Device ID00613994722089
NIH Device Record Key3330be63-bf5e-4ee8-8aa6-6fd510466619
Commercial Distribution StatusIn Commercial Distribution
Brand NamePISCES-QUAD PLUS™
Version Model Number3888-56
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 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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length56 Centimeter
Length56 Centimeter
Length56 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994722089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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 Date2014-09-23

On-Brand Devices [PISCES-QUAD PLUS™]

00613994951694LEAD 3888-33 PISCES QUAD BLU TRQ PAPER
00613994951687LEAD 3888-45 PISCES QUAD BLU TRQ PAPER
00613994951670LEAD 3888-56 PISCES QUAD BLU TRQ PAPER
00613994722096LEAD 3888-45 PISCES QD 12MM SP US EMANUA
00613994722089LEAD 3888-56 PISCES QD 12MM SP US EMANUA

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