Catalog Number

LP4.5-DRF4B

Brand Name

PRECICE® Plating System

Version/Model Number

LP4.5-DRF4B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K192181

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

fb5f8b65-5bc2-422f-b27d-3e7a4aa68662

Public Version Date

March 12, 2020

Public Version Number

3

DI Record Publish Date

January 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-