Catalog Number

-

Brand Name

GRACE MEDICAL FLUOROPLASTIC PISTON

Version/Model Number

402-400

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

K060518

Product Code

ETB

Product Code Name

PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Public Device Record Key

f7b9004b-e3e9-45a0-aa35-81606dcd4847

Public Version Date

March 23, 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

-