Catalog Number

K303

Brand Name

PMI

Version/Model Number

K303

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)

Yes

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

-

Product Code Name

-

Public Device Record Key

c2ff99e1-9c67-43a4-85a6-8083e19a9058

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

00812608021437

Quantity per Package

20

Contains DI Package

00812608021420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box