Catalog Number

-

Brand Name

Footswitch

Version/Model Number

E104201USMP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

QAI

Product Code Name

Powered Microneedle Device

Public Device Record Key

283c57ab-2735-4bc0-ab73-690fa0ee6f4e

Public Version Date

November 29, 2021

Public Version Number

3

DI Record Publish Date

January 01, 2020

Package DI Number

EMTDE104201USMP1

Quantity per Package

1

Contains DI Package

EMTDE104201USMP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-