Catalog Number

SF-4XL

Brand Name

ORI

Version/Model Number

SF-4XL

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

-

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

54f9195d-e1f4-4a5b-b3ce-a5d3f3f92d07

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2017

Package DI Number

00854150007170

Quantity per Package

26

Contains DI Package

00854150007163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case