Catalog Number

-

Brand Name

SonicOne O.R.

Version/Model Number

E-SOC-FTCH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

d5f27f28-255d-4052-a0bd-9592de5036ad

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Package DI Number

10841626103716

Quantity per Package

5

Contains DI Package

00841626103719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-