Catalog Number

SF-4XXL-EL

Brand Name

ORI

Version/Model Number

SF-4XXL-EL

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120045,K120045

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

5d063830-a6c4-4a61-8cfe-5f81e4f7a291

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

November 09, 2018

Package DI Number

00850003355047

Quantity per Package

24

Contains DI Package

00850003355030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case