Catalog Number

A200-3000

Brand Name

O-pak

Version/Model Number

A200-3000

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

Yes

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

KDD

Product Code Name

Kit, Surgical Instrument, Disposable

Public Device Record Key

d3703822-de14-407a-bb6e-fb2d227118d7

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Package DI Number

10814639022039

Quantity per Package

6

Contains DI Package

00814639022032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box