GUDID 00613994756626

LEAD 387460 OCTAD 1X8 TEST STIM eMAN US

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00613994756626
NIH Device Record Keya2259ca6-e8be-4939-88c8-4d010aa2c77e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number387460
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

Length60 Centimeter
Length60 Centimeter
Length60 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994756626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (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 Date2015-06-08

Devices Manufactured by MEDTRONIC, INC.

00763000449711 - INTERSTIM® II2025-12-16 INS 3058 IS II EMAN US
00199150062980 - NA2025-12-15 CUSTOM PACK BB9H69R15 HLO H/LW/VAV
00199150063390 - NA2025-12-15 CUSTOM PACK 10D80R1 ACC TEMP PROBE
00199150063550 - NA2025-12-15 CUSTOM PACK BB7W91R29 HLO OH PACK2
00763000929374 - NA2025-12-15 WIRELESS RECHARGER P720R1 ALTAVIVA
20199150061970 - NA2025-12-08 CUSTOM PACK BB12R02R3 5PK ACC STRNG SUC
00199150062027 - NA2025-12-08 CUSTOM PACK BB12R85R AVL 3/8 ECCPK
20199150062229 - NA2025-12-08 CUSTOM PACK BB1Q47R3 5PK ACC TABLE

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