The Q-TRAK™ Subcutaneous Electrode

GUDID 00802526563201

Electrode

CAMERON HEALTH, INC.

Endocardial defibrillation lead
Primary Device ID00802526563201
NIH Device Record Key32e71cc3-aaa7-4fcf-93da-936eaa02f813
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Q-TRAK™ Subcutaneous Electrode
Version Model Number3400
Company DUNS017134557
Company NameCAMERON HEALTH, 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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526563201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

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 Date2014-09-24

Devices Manufactured by CAMERON HEALTH, INC.

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00802526531019 - The Q-GUIDE™ Electrode Insertion Tool2018-07-06 Electrode Insertion Tool
00802526531033 - S-ICD® System Magnet2018-07-06 Magnet
00802526542244 - Q-TECH™2018-07-06 Power Supply for S-ICD Programmer 3200
00802526553707 - HP OFFICEJET 100 Mobile Printer2018-07-06 Printer
00802526562808 - SQ-RX® PULSE GENERATOR2018-07-06 SQ-RX Pulse Generator

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