FDA.reportPublic FDA data

The Q-GUIDE™ Electrode Insertion Tool

Primary DI
00802526569401
Brand
The Q-GUIDE™ Electrode Insertion Tool
Company
CAMERON HEALTH, INC.
Model
4710
Device description
Electrode Insertion Tool
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110042033
P110042039

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110042033SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042039SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526569401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526569401008025265694018025265694010802526569401

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017134557
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526521300SQ-RX® PULSE GENERATOR10102014-09-24
00802526562808SQ-RX® PULSE GENERATOR10102014-09-24
00802526563201The Q-TRAK™ Subcutaneous Electrode34002014-09-24
00802526542206Q TECH32002014-09-24
00802526524806S-ICD® System Patient Screening Tool47442014-09-24
00802526531019The Q-GUIDE™ Electrode Insertion Tool47102014-09-24
00802526531033S-ICD® System Magnet47302014-09-24
00802526542244Q-TECH™32042015-01-08
00802526553707HP OFFICEJET 100 Mobile Printer47002014-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04035479182830Acticor Sky VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182847Acticor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183011Rivacor Aura VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183059Rivacor Rise VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183066Rivacor Rise VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479185695Rivacor Aura VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
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05414734500586NAST. JUDE MEDICAL, INC.LWS2025-05-07
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05415067050090Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWS2024-11-13
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00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
05415067049414Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049421Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049469Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049476Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
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