Catalog Number

221000

Brand Name

LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)

Version/Model Number

LFD-1000

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

607234de-55d5-4a62-8662-a4ed426709dc

Public Version Date

March 05, 2020

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

20859623006135

Quantity per Package

10

Contains DI Package

00859623006117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box