Catalog Number

NM-345Y

Brand Name

Smart Cable NMT Module and Accessories

Version/Model Number

NM-345Y

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

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,K201949

Product Code

KOI

Product Code Name

Stimulator, Nerve, Peripheral, Electric

Public Device Record Key

c200f3b7-1bb9-410d-85b9-5b27a58d6664

Public Version Date

October 05, 2021

Public Version Number

1

DI Record Publish Date

September 27, 2021

Package DI Number

14931921006716

Quantity per Package

10

Contains DI Package

04931921006719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box