SonicOne O.R.

GUDID 00841626100930

SonicOne O.R.Ultrasonic Surgical Aspiration System/Generator

MISONIX, INC.

Ultrasonic surgical system generator
Primary Device ID00841626100930
NIH Device Record Key9b5afc22-b637-4790-8f8f-058ec0cb3b91
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonicOne O.R.
Version Model NumberE-SOGEN-OR
Company DUNS065963449
Company NameMISONIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841626100930 [Primary]

FDA Product Code

LFLInstrument, Ultrasonic Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-24
Device Publish Date2016-09-24

On-Brand Devices [SonicOne O.R. ]

10841626101453SonicOne O.R. Irrigation TubeSet
00841626101456SonicOne O.R. Irrigation TubeSet
00841626101968SharpVac Debridement Probe with Aspiration
00841626101494SonicOne O.R. Wide Hatch Probe Kit
00841626101470SonicOne O.R. Hatched Titanium Probe Kit
00841626101432SonicOne O.R. Micro Bone Shaver
00841626101418SonicOne O.R. 360 Bone Shaver
00841626101395SonicOne O.R. Cylindrical Titanium Probe Kit
00841626101371SonicOne O.R. Curette Style Titanium Probe Kit
00841626101357SonicOne O.R. Extra Large Blade
00841626101340SonicOne O.R. Debridement Probe With Aspiration
00841626101333SonicOne O.R. Small Blade
00841626101319SonicOne O.R. Large Blade, Serrated
00841626101296SonicOne O.R. Large Long Curved Blade
00841626100930SonicOne O.R.Ultrasonic Surgical Aspiration System/Generator
10841626103716Flat Tip Clinic Housing
00841626103702Flat Tip Clinic Probe
00841626101982Flat Tip Handpiece Housing

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