Catalog Number

66800474

Brand Name

Versajet

Version/Model Number

66800474

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143115,K143115

Product Code

FQH

Product Code Name

Lavage, Jet

Public Device Record Key

6d0b656b-4a68-4477-86ed-69998f23bbbc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

30040565125498

Quantity per Package

25

Contains DI Package

00040565125497

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE