FDA.reportPublic FDA data

TAC-S/EFLEX

Primary DI
03596010470683
Brand
TAC-S/EFLEX
Company
Smith & Nephew, Inc.
Model
7209637
Catalog number
7209637
Device description
TAC-S E-FLEX VULCAN
Published
2015-08-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
HRXARTHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990859000DEFLECTABLE TAC ELECTROTHERMAL PROBEOratec Interventions, Inc.1999-06-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010470683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010470683035960104706833596010470683

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system probe, reusableA hand-held surgical device designed to connect to a radio-frequency ablation system generator to deliver radio-frequency (RF) energy to a targeted operative site for soft-tissue coagulation/ablation (i.e., thermal ablation, therapeutic lesion, or denervation). It is intended to be used in percutaneous, laparoscopic, or intraoperative procedures to ablate tissue typically in the brain/nerves, kidney, liver, and/or in small or metastatic tumours. The device typically includes multiple electrodes that extend from its tip, once deployed, and which cover the site to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30
03596010544230JOURNEY71461016714610162015-08-30

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Primary DI, Brand, Company table
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00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
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00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
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00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
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00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
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00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
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