Catalog Number

081710748

Brand Name

Performa

Version/Model Number

081710748

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

-

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

K151070

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

e50d9fe1-3fee-4b43-a3c6-5a7c775e4917

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-