Catalog Number

221050

Brand Name

LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE

Version/Model Number

LFD-2000

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

ORZ

Product Code Name

Eyelid thermal pulsation system

Public Device Record Key

09a06cf3-bc19-42bb-9c4f-7e790857caa3

Public Version Date

March 05, 2020

Public Version Number

7

DI Record Publish Date

December 24, 2016

Package DI Number

20859623006333

Quantity per Package

10

Contains DI Package

00859623006315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box