SonicOne Clinic

Primary DI
00841626101012
Brand
SonicOne Clinic
Company
MISONIX, INC.
Model
E-SOP-R2
Device description
SonicOne Clinic Copper Angled Titanium Probe Kit (w/Wrench)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LFLInstrument, Ultrasonic Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841626101012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841626101012008416261010128416261010120841626101012

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system handpiece tip, single-useA sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065963449
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841626101982SonicOne O.R.E-SOC-FTHH2021-05-03
00841626103702SonicOne O.R.E-SOC-FTC2021-05-03
10841626103716SonicOne O.R.E-SOC-FTCH2021-05-03
00841626103610neXus130-35-55022020-07-13
00841626103580neXus 120-31-13C32020-07-01
00841626102835neXus100-10-00022020-03-12
00841626102453neXus100-10-00002020-02-24
00841626102484neXus100-50-00002020-02-24
00841626102521neXus 100-21-00012020-02-24
00841626102538neXus100-24-00012020-02-24
00841626102545neXus100-25-00012020-02-24
00841626102569neXus100-60-00002020-02-24
00841626102576neXus100-61-00002020-02-24
00841626102583neXus100-62-00002020-02-24
00841626102590neXus100-63-00002020-02-24
00841626102606neXus100-70-00002020-02-24
00841626102613neXus100-71-00002020-02-24
00841626102651neXus100-21-00022020-02-24
00841626102668neXus100-21-00032020-02-24
00841626102712neXus100-21-00002020-02-24

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Primary DI, Brand, Company table
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