Catalog Number

OR4001

Brand Name

Biotronix Healthcare Suture Removal Tray

Version/Model Number

OR4001

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"

Yes

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

7a2edf6c-bbcc-42fd-a754-0c6c3b37792f

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

Package DI Number

10850005165290

Quantity per Package

50

Contains DI Package

00850005165293

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case