Catalog Number

6855DPHA-5

Brand Name

PKIT HANA DISTRACTION PAD HIP ARTHR

Version/Model Number

6855DPHA-1

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"

Yes

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

-

Product Code

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

e0609d33-1fd8-4c6b-b647-48af2048d5a8

Public Version Date

July 16, 2021

Public Version Number

2

DI Record Publish Date

April 26, 2021

Package DI Number

10842430115377

Quantity per Package

5

Contains DI Package

00842430115370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case