Catalog Number

-

Brand Name

SteriGear

Version/Model Number

RE4068P-01

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)

Yes

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

b71c6998-afb2-48cf-82c9-711ad4f77a55

Public Version Date

May 12, 2021

Public Version Number

2

DI Record Publish Date

November 12, 2020

Package DI Number

10851616002011

Quantity per Package

10

Contains DI Package

00851616002014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-