Catalog Number

-

Brand Name

Core Values

Version/Model Number

8709

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FQH

Product Code Name

Lavage, Jet

Public Device Record Key

8ccd7699-2d95-4775-a634-b9537cec9b34

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

10034197008706

Quantity per Package

48

Contains DI Package

00034197008709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case