Catalog Number

-

Brand Name

GRACE PISTON

Version/Model Number

412-475

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K060518

Product Code

ETB

Product Code Name

PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Public Device Record Key

8b99cfa5-ebc2-4d3e-b908-ad363e23680b

Public Version Date

October 05, 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

-