Catalog Number

P640954

Brand Name

Pro Advantage

Version/Model Number

P640954

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

K042301,K042301,K042301

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

04278ff9-dc29-41f5-8e58-94d54fdda81d

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

M220P6409543

Quantity per Package

400

Contains DI Package

M220P6409542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case