Catalog Number

-

Brand Name

Onpro kit

Version/Model Number

9002136

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

KZH

Product Code Name

Introducer, Syringe Needle

Public Device Record Key

7e565691-733c-4525-a18a-15c78004c0a6

Public Version Date

October 02, 2019

Public Version Number

1

DI Record Publish Date

September 24, 2019

Package DI Number

10355513192016

Quantity per Package

20

Contains DI Package

00355513192019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case