Catalog Number

-

Brand Name

CycloTens Refill Pak

Version/Model Number

50054A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133979,K133979,K133979

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

40fa0a53-b6b9-4b55-ad90-6af881af4c39

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 24, 2017

Package DI Number

20370914013019

Quantity per Package

120

Contains DI Package

00370914013015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-