Catalog Number

RR1203

Brand Name

SIDEKICK

Version/Model Number

RR1203

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

-

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Public Device Record Key

f6263b5b-2d7e-4420-aef0-5b32d4fe165d

Public Version Date

March 24, 2022

Public Version Number

5

DI Record Publish Date

October 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-