Catalog Number

100-0012

Brand Name

PRCT2

Version/Model Number

100-0012

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143721

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

83ea9b0a-da65-4662-9491-65b6d58a9841

Public Version Date

October 08, 2021

Public Version Number

4

DI Record Publish Date

June 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-