Catalog Number

ORI-SDL-LEAD

Brand Name

ORI

Version/Model Number

ORI-SDL-LEAD

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

abfcf92c-c8a3-47e9-8555-e26f52f31903

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2020

Package DI Number

00854150007279

Quantity per Package

5

Contains DI Package

00854150007262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case