Catalog Number

-

Brand Name

Famidoc

Version/Model Number

FDES105

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130723,K130723

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

f95c5da8-c3a0-4c31-a228-0cc25d2d560e

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

December 29, 2016

Package DI Number

10854314007500

Quantity per Package

40

Contains DI Package

00854314007503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-