Catalog Number

P003

Brand Name

External Remote Controller

Version/Model Number

P003

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

-

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

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

5a7a143c-66c8-4ec8-919d-d0bee27080ad

Public Version Date

October 14, 2021

Public Version Number

6

DI Record Publish Date

October 15, 2015

Package DI Number

00195377000484

Quantity per Package

1

Contains DI Package

00856719002039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pelican Case