Catalog Number

5345

Brand Name

PKIT, ULTRA SHOULDER, MULTIFLEX PAD

Version/Model Number

5345-1

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

7fedb728-a554-491d-a908-382898f700f0

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

May 17, 2019

Package DI Number

10842430109079

Quantity per Package

3

Contains DI Package

00842430109072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box