Catalog Number

800-000-056

Brand Name

FREMSLIFE

Version/Model Number

APTI-GEL 800-000-056

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

K080902,K080902,K080902

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

90a46129-855c-4d5c-b6f4-53bc4bfcbb58

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

January 28, 2018

Package DI Number

18055765540017

Quantity per Package

50

Contains DI Package

08055765540010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-