Catalog Number

SF-SDT-1

Brand Name

ORI Self Donning Tabs Kit

Version/Model Number

SF-SDT-1

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"

-

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

602a6a75-cd6b-4e4a-82c6-4c5c90eff544

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

August 01, 2017

Package DI Number

00854150007149

Quantity per Package

200

Contains DI Package

00854150007132

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case