Catalog Number

-

Brand Name

Surgical irrigator

Version/Model Number

MT-xxxxx

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

bfe24fbc-63b8-48cd-a032-4e56a4862c25

Public Version Date

August 15, 2018

Public Version Number

3

DI Record Publish Date

July 13, 2015

Package DI Number

10803622104067

Quantity per Package

5

Contains DI Package

00803622104060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE