Catalog Number

-

Brand Name

Pre-Processing Sink

Version/Model Number

83-S8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2018

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

K162120

Product Code

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Public Device Record Key

d597d277-06fe-44fc-b2cb-b2ca3e4c1e44

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

October 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-