Catalog Number

10240016

Brand Name

HEALON DUET PRO

Version/Model Number

10240016

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

bd912908-a49c-43be-b9f2-21ffd2c3216c

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

July 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-