Catalog Number

6855DP-5

Brand Name

PKIT HANA DISTRACTION PAD W/STRAP

Version/Model Number

6855DP-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

3a218b8a-cbe6-470d-af47-d570ea6fa8e8

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

April 07, 2021

Package DI Number

10842430115308

Quantity per Package

5

Contains DI Package

00842430115301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case