FDA.reportPublic FDA data

SonaStar

Primary DI
00841626100084
Brand
SonaStar
Company
MISONIX, INC.
Model
CFSM6-C141
Device description
SonaStar ConMed Sabre 2400 & Model 7500 Umbilical Cable
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
LFLInstrument, Ultrasonic Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
LFLInstrument, Ultrasonic SurgicalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062471000ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RFMisonix, Inc.2006-10-26LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841626100084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841626100084008416261000848416261000840841626100084

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065963449
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841626100664BoneScalpelBCM-GN2016-09-24
00841626100299SonaStar E0702ABC072016-09-26
00841626100329SonaStarMXA-TRAY2016-09-24
00841626101081BoneScalpel & SonicOne (O.R.)E-SYSTRAY2016-09-24
00841626102606neXus100-70-00002020-02-24
00841626102613neXus100-71-00002020-02-24
00841626102835neXus100-10-00022020-03-12
00841626100565SonaStarCFSM5-T1012016-09-24
00841626103719SonicOne O.R.E-SOC-FTCH2021-05-03
00841626101982SonicOne O.R.E-SOC-FTHH2021-05-03
00841626103702SonicOne O.R.E-SOC-FTC2021-05-03
10841626103716SonicOne O.R.E-SOC-FTCH2021-05-03
00841626103603neXus130-35-55022020-07-13
00841626103610neXus130-35-55022020-07-13
00841626103580neXus 120-31-13C32020-07-01
00841626102941neXus100-29-00002020-02-24
00841626102958neXus110-31-11102020-02-24
00841626102965neXus110-31-11202020-02-24
00841626102972neXus110-31-11212020-02-24
00841626102989neXus110-31-11252020-02-24

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Primary DI, Brand, Company table
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00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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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00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02