Catalog Number

-

Brand Name

SteriGear

Version/Model Number

A4092-81

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FCN

Product Code Name

Urinary drainage collection kit, for indwelling catheter

Public Device Record Key

2d967250-c0b3-4eb7-89a1-f90f68848bbd

Public Version Date

May 12, 2021

Public Version Number

2

DI Record Publish Date

November 13, 2020

Package DI Number

10851616002004

Quantity per Package

20

Contains DI Package

00851616002007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-