Catalog Number

221001

Brand Name

LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE)

Version/Model Number

LFD-1100

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

1c6c6dac-5994-4a8b-9194-c14d170f7b26

Public Version Date

March 05, 2020

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

20859623006234

Quantity per Package

10

Contains DI Package

00859623006216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box