Catalog Number

240100

Brand Name

LIPIFLOW SYSTEM ACTIVATOR II CABLE KIT

Version/Model Number

CBL-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

-

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

81d13917-e6d8-48f7-9dbb-6ca6562cb7e8

Public Version Date

October 04, 2019

Public Version Number

5

DI Record Publish Date

December 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-