Catalog Number

S-SC-NDK

Brand Name

Smart VIdeo-Stylet Monitor

Version/Model Number

S-SC-NDK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 28, 2120

Issuing Agency

In HIBCC

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

-

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

CCW

Product Code Name

Laryngoscope, Rigid

Public Device Record Key

f089b93b-3eda-4f7e-a882-7ca17d7340b1

Public Version Date

December 07, 2020

Public Version Number

1

DI Record Publish Date

November 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-