Catalog Number

-

Brand Name

MEGA3

Version/Model Number

MEGA3

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Public Device Record Key

bcbd87c2-9585-48ff-8ba7-8596f1620ab5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2017

Package DI Number

40817713023015

Quantity per Package

4

Contains DI Package

10817713023014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE