Catalog Number

634464

Brand Name

OptraPol

Version/Model Number

634464

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 18, 2022

Issuing Agency

In HIBCC

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

EHJ

Product Code Name

DISK, ABRASIVE

Public Device Record Key

cc941766-d500-4679-a1d8-b895a3649327

Public Version Date

July 19, 2022

Public Version Number

2

DI Record Publish Date

August 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-