Catalog Number

AF-201P

Brand Name

Smart Cable NMT Module and Accessories

Version/Model Number

AF-201P

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

K201949

Product Code

KOI

Product Code Name

Stimulator, Nerve, Peripheral, Electric

Public Device Record Key

4d7985a6-6115-4e1f-8c1d-0c1619d3b099

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

June 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-