Catalog Number

0210112000E

Brand Name

InterPulse

Version/Model Number

0210112000E

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

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

3478380b-0fa0-4be0-af9f-6f689dbc5659

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

34546540861697

Quantity per Package

6

Contains DI Package

04546540861696

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack