SonicOne O.R.

GUDID 10841626103716

Flat Tip Clinic Housing

MISONIX, INC.

Soft-tissue ultrasonic surgical system handpiece tip, single-use
Primary Device ID10841626103716
NIH Device Record Keyd5f27f28-255d-4052-a0bd-9592de5036ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonicOne O.R.
Version Model NumberE-SOC-FTCH
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841626103719 [Primary]
GS110841626103716 [Package]
Contains: 00841626103719
Package: [5 Units]
In Commercial Distribution

FDA Product Code

LFLInstrument, Ultrasonic Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-11
Device Publish Date2021-05-03

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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