Catalog Number

6855L-6

Brand Name

PKIT HANA LATERAL SET WITH BOOT

Version/Model Number

6855L-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

36bb3882-1476-47c3-8dbb-c7e18f9e7ac4

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Package DI Number

10842430115438

Quantity per Package

6

Contains DI Package

00842430115431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE