Catalog Number

6855DPS-10

Brand Name

PKIT HANA DISTRACTION PAD STRAP

Version/Model Number

6855DPS-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

FMQ

Product Code Name

Restraint, Protective

Public Device Record Key

250d87c3-dc7d-4183-bb12-5173024557b8

Public Version Date

July 15, 2021

Public Version Number

2

DI Record Publish Date

June 21, 2021

Package DI Number

10842430115360

Quantity per Package

10

Contains DI Package

00842430115363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case