Catalog Number

-

Brand Name

Scope Assist Flushing Sink (SAFS)

Version/Model Number

S8

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

K162120

Product Code

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Public Device Record Key

948a824c-24d0-4d49-9009-b82dd00727a6

Public Version Date

September 17, 2018

Public Version Number

4

DI Record Publish Date

May 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-