Catalog Number

-

Brand Name

Portex

Version/Model Number

55-4090

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYI

Product Code Name

PERCUSSOR, POWERED-ELECTRIC

Public Device Record Key

0833b35a-8386-4591-8a7f-a823d35e3f88

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 11, 2016

Package DI Number

50788942540901

Quantity per Package

40

Contains DI Package

10788942540903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE