Catalog Number

-

Brand Name

CLEAR FLUSH

Version/Model Number

SS9-1MM90

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 20, 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)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

HAE

Product Code Name

Rongeur, Manual

Public Device Record Key

59a91e19-8cbf-48cd-b457-c282f3ce2079

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

January 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-