Catalog Number

02112712S

Brand Name

NA

Version/Model Number

02.112.712S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K201321,K203414,K201321,K203414

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

c245d8c7-9fe7-4f15-8f86-af247a4c99e5

Public Version Date

April 29, 2022

Public Version Number

2

DI Record Publish Date

February 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-