GUDID 08714729121558

Enhanced Steering Kit with Stylet Cap 30cm

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Central nervous system electrical stimulation system lead stylet
Primary Device ID08714729121558
NIH Device Record Keyc2fbdd4f-08d1-42d9-aea6-e45fdfe46eb4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSC-4395-30
Company DUNS824951958
Company NameBOSTON SCIENTIFIC NEUROMODULATION CORPORATION
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729121558 [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 Number4
Public Version Date2024-03-19
Device Publish Date2015-11-09

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

00191506048464 - GX1™2025-10-07 Radiofrequency Generator 2.0A, 120V
00191506048518 - GX1™2025-10-07 Radiofrequency Generator 2.0A, 220V
00191506048563 - GX1™2025-10-07 Radiofrequency Generator 2.0A, 240V
00191506059309 - GX1™2025-10-07 Radiofrequency Generator
00191506059330 - GX1™2025-10-07 GX1 RF GENERATOR HW 120V
00191506059347 - GX1™2025-10-07 GX1 RF GENERATOR HW 220V
00191506059354 - GX1™2025-10-07 GX1 RF GENERATOR HW 240V
08714729951254 - Spectra WaveWriter™2025-09-30 Implantable Pulse Generator Kit

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