Catalog Number

OR4004

Brand Name

Biotronix Healthcare

Version/Model Number

OR4004

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

21a1849c-7d42-44f5-8bcb-90592bfa6bea

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

October 04, 2019

Package DI Number

10850005165054

Quantity per Package

20

Contains DI Package

00850005165057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case