Catalog Number

5500-25S-316

Brand Name

Sonopet iQ

Version/Model Number

550025S316

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

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

fee3c8f4-163c-4591-a4f5-6cd6e6f95d9e

Public Version Date

February 22, 2022

Public Version Number

2

DI Record Publish Date

May 02, 2019

Package DI Number

37613327422420

Quantity per Package

4

Contains DI Package

07613327422429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack