Catalog Number

5500-25B-110

Brand Name

Sonopet iQ

Version/Model Number

550025B110

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

1adbd901-0303-4310-b3de-fb90e53a588d

Public Version Date

September 23, 2022

Public Version Number

3

DI Record Publish Date

June 14, 2021

Package DI Number

37613327548106

Quantity per Package

4

Contains DI Package

07613327548105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack