Catalog Number

002-H-00010

Brand Name

RIVAL VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM

Version/Model Number

2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

K140876

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

e590940d-823f-4b12-9c0c-9e6fb4608f19

Public Version Date

November 06, 2019

Public Version Number

1

DI Record Publish Date

October 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-