Freedom Stim - 2" x 3.5" Butterfly w/ snap - PEPIN MANUFACTURING, INC.

Duns Number:807703996

Device Description: 2" x 3.5" Butterfly w/ snap

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Freedom Stim

Version/Model Number

NC89800

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070807,K070807,K070807,K070807,K070807

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

8fa55e64-f336-4f77-b1f0-7564e9ac5854

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

January 19, 2017

Additional Identifiers

Package DI Number

00677346320767

Quantity per Package

100

Contains DI Package

00677346310744

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PEPIN MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8