Catalog Number

150-6600-204-S

Brand Name

Distal radius plate 7/3 holes,right, polyaxial

Version/Model Number

150-6600-204-S

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"

Yes

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

-

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

4bb0fc32-f84f-41a7-acfd-ceb9fed07a02

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2016

Package DI Number

EMAH1506600204S1

Quantity per Package

1

Contains DI Package

EMAH1506600204S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-