Catalog Number

6854NH-6

Brand Name

PKIT HANA SUPINE, W/ BOOT, NO HEAD

Version/Model Number

6854NH-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

5625fad7-adc0-4310-bff2-69eff11ed3b0

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

Package DI Number

10842430115407

Quantity per Package

6

Contains DI Package

00842430115400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case