Catalog Number

-

Brand Name

HA TOTAL PROSTHESIS

Version/Model Number

109

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

K963752

Product Code

ETA

Product Code Name

REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Public Device Record Key

d4c08a0a-fd15-4539-a0c7-962a02c8b0fb

Public Version Date

July 27, 2020

Public Version Number

4

DI Record Publish Date

February 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-