Catalog Number

N099001

Brand Name

Pro Advantage

Version/Model Number

N099001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K930284,K930284

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Public Device Record Key

bc84a874-8a36-466a-ba1c-61f5f5b99980

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

M220N0990015

Quantity per Package

4

Contains DI Package

M220N0990018

Package Discontinue Date

-

Package Status

-

Package Type

Case