Catalog Number

0207068000

Brand Name

NA

Version/Model Number

0207068000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2016

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

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

8242cfb7-af97-4ded-8209-7bcf5ec173bb

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

34546540860065

Quantity per Package

12

Contains DI Package

04546540860064

Package Discontinue Date

September 23, 2016

Package Status

Not in Commercial Distribution

Package Type

pack