Catalog Number

-

Brand Name

PowerDot

Version/Model Number

SAE-MC-PD-01MTBL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

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"

-

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

K180865

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

dcfecee6-a48e-440f-bade-cc2f99109fce

Public Version Date

December 18, 2019

Public Version Number

1

DI Record Publish Date

December 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-