Catalog Number

15104

Brand Name

ExSept Plus

Version/Model Number

100 mL

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082858,K082858

Product Code

FQH

Product Code Name

Lavage, Jet

Public Device Record Key

dc6998fe-8660-4a3c-98ad-68fe9fa13db7

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

August 29, 2016

Package DI Number

20898021000109

Quantity per Package

24

Contains DI Package

00898021000105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case