Catalog Number

7815

Brand Name

PremierPro

Version/Model Number

7815

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

-

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

ITJ

Product Code Name

Walker, Mechanical

Public Device Record Key

e5ac1f46-5937-4188-a757-9dc88417ddff

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 26, 2020

Package DI Number

10818566012484

Quantity per Package

60

Contains DI Package

00818566012487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case