Catalog Number

SS-EVAC

Brand Name

ORI

Version/Model Number

SS-EVAC

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

db726d93-9640-4566-8936-91a2c0513d95

Public Version Date

January 06, 2021

Public Version Number

1

DI Record Publish Date

December 29, 2020

Package DI Number

00854150007293

Quantity per Package

25

Contains DI Package

00854150007286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case