Catalog Number

-

Brand Name

Small VLC "L" Plate Right

Version/Model Number

300-56-002

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

K130964

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

2043070a-50c3-415d-9e55-5c481ae6aeaf

Public Version Date

April 06, 2022

Public Version Number

4

DI Record Publish Date

March 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-