Catalog Number

OZ 7580275

Brand Name

OPERON

Version/Model Number

OZ 7580275

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

-

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

92fc3481-c329-4397-be50-50ec6e63fa21

Public Version Date

March 30, 2022

Public Version Number

1

DI Record Publish Date

March 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-