Catalog Number

-

Brand Name

Flex H/A®

Version/Model Number

0580

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K904239

Product Code

ETA

Product Code Name

REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Public Device Record Key

2d9dd550-b89c-4a6c-9612-333c30b7de01

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-