Catalog Number

-

Brand Name

LOTFANCY

Version/Model Number

11M-2229-S

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

44d3615d-2f3d-4c32-9bac-d27fbf4978b3

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 27, 2020

Package DI Number

10697360273013

Quantity per Package

12

Contains DI Package

06973602730016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-