Catalog Number

-

Brand Name

TopRx 1st Tier UP

Version/Model Number

AN 3550TRX

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152339,K152339,K152339,K152339

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

019c03d9-590f-48a5-a738-73e28c19eac7

Public Version Date

June 10, 2022

Public Version Number

1

DI Record Publish Date

June 02, 2022

Package DI Number

00761059551874

Quantity per Package

10

Contains DI Package

00761059550877

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve