GUDID 00813250017243

Cable, Cosman CSK for S/N Generator

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Radio-frequency ablation system
Primary Device ID00813250017243
NIH Device Record Key77c9ba47-bf8b-4e0f-ae46-e37cbaef2f8f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberC126-TC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813250017243 [Primary]

FDA Product Code

GXDGENERATOR, LESION, RADIOFREQUENCY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-08
Device Publish Date2017-08-21

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

08714729888734 - Precision™2024-09-24 M8 Adapter, 15cm
08714729888758 - Precision™2024-09-24 M8 Adapter, 55cm
08714729893271 - Precision™2024-09-24 S8 Adapter, 15cm
08714729893288 - Precision™2024-09-24 S8 Adapter, 55cm
08714729897804 - NA2024-08-21 Installer for BN3.1
08714729897811 - NA2024-08-21 Clinician Programmer
08714729897835 - Precision Novi™2024-08-21 Implantable Pulse Generator Kit
08714729897873 - NA2024-08-21 Clinican Programmer (Refurbished)

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