Catalog Number

-

Brand Name

SteriGear

Version/Model Number

REA4094-01

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

6e2a84be-0194-44db-a987-16a1cbaf4f3e

Public Version Date

May 12, 2021

Public Version Number

2

DI Record Publish Date

November 13, 2020

Package DI Number

10851616002073

Quantity per Package

10

Contains DI Package

00851616002076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-