Catalog Number

00324

Brand Name

UNOLOK

Version/Model Number

19 G X ¾"

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"

Yes

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

K953252,K953252,K953252,K953252

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

59ee0172-7cff-479c-9497-004fc7f13c0c

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

April 26, 2017

Package DI Number

18903347003248

Quantity per Package

100

Contains DI Package

08903347003241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX