Catalog Number

7704

Brand Name

PremierPro

Version/Model Number

7704

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

IPR

Product Code Name

Crutch

Public Device Record Key

b1d12b84-d2ff-4009-8504-d24afd01c0cc

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Package DI Number

10854344002636

Quantity per Package

6

Contains DI Package

00854344002639

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case