Catalog Number

D6113

Brand Name

Dynax® heavy body

Version/Model Number

D6113

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

-

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

K171562

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

c11c22b5-17ed-4fe3-ae78-51e80605b195

Public Version Date

January 24, 2020

Public Version Number

3

DI Record Publish Date

April 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-