Catalog Number

-

Brand Name

Sanibel

Version/Model Number

Tab electrode

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"

-

For Single-Use

Yes

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

1a87db35-0539-4619-b608-f5184ab89f9b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 08, 2018

Package DI Number

05711117180589

Quantity per Package

60

Contains DI Package

05711117199345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box