Catalog Number

10240011

Brand Name

HEALON PRO

Version/Model Number

10240011

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"

Yes

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

LZP

Product Code Name

AID, SURGICAL, VISCOELASTIC

Public Device Record Key

02f4fc22-c9a1-4c8b-851f-daefaa80ac81

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

June 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-