Catalog Number

-

Brand Name

SYSTEM 83 PLUS

Version/Model Number

SYSTEM 83 PLUS 2

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Public Device Record Key

94e3e4b5-88e4-435e-b127-435fe35bd279

Public Version Date

April 30, 2020

Public Version Number

5

DI Record Publish Date

September 25, 2016

Package DI Number

B21583PLUS2

Quantity per Package

1

Contains DI Package

SYSTEM83PLUS2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box