Catalog Number

5322PV

Brand Name

PKIT, RWF, LPV CUSHION, ARM CRADLES

Version/Model Number

5322PV-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

59761482-2c20-4c59-8ac6-6538fa0f21fb

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 31, 2019

Package DI Number

10842430108935

Quantity per Package

6

Contains DI Package

00842430108938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box