Catalog Number

01-3563

Brand Name

DISTRACTION SYSTEM

Version/Model Number

01-3563

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

-

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

HXC

Product Code Name

WRENCH

Public Device Record Key

a6a813f6-1876-4b94-980a-7e4915744c10

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-