Catalog Number

-

Brand Name

OPELAIII Antibacterial Urethane Pad

Version/Model Number

-H

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 07, 2022

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

FQP

Product Code Name

Lamp, Operating-Room

Public Device Record Key

41ea31b5-895a-4b7d-b702-3e73f6731a5f

Public Version Date

July 08, 2022

Public Version Number

2

DI Record Publish Date

December 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-