Catalog Number

303001

Brand Name

METRON

Version/Model Number

303001

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012522,K012522

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

21d74a03-2aea-4443-ba7b-651569e2e1b8

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10885914004057

Quantity per Package

4

Contains DI Package

00885914004050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-