Catalog Number

OZ 7552075

Brand Name

OPERON

Version/Model Number

OZ 7552075

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 2021

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

-

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

LWG

Product Code Name

SURGICAL TABLE CUSHION

Public Device Record Key

27e6f29c-af58-4f24-9345-fd6e77d8da1f

Public Version Date

April 29, 2021

Public Version Number

4

DI Record Publish Date

January 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-