FDA.reportPublic FDA data

neXus

Primary DI
00841626102453
Brand
neXus
Company
MISONIX, INC.
Model
100-10-0000
Device description
neXus Ultrasonic Surgical Aspirator System/Console
Published
2020-02-24
Public version status
New
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
K190160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190160000neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.2019-05-30LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841626102453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841626102453008416261024538416261024530841626102453

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system generatorAn electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.

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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