Catalog Number

-

Brand Name

Belifu

Version/Model Number

50100-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2022

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

7c1efce1-ffdf-44cc-8e89-e237f279fa5d

Public Version Date

June 15, 2022

Public Version Number

2

DI Record Publish Date

June 15, 2021

Package DI Number

16973602730051

Quantity per Package

7

Contains DI Package

06973602730054

Package Discontinue Date

June 15, 2022

Package Status

Not in Commercial Distribution

Package Type

INNER