Smart Video-Stylet - Smart Video-Stylet Dispenser Box of 15 disposable - SMART VIDEO-STYLET, LLC

Duns Number:113503058

Device Description: Smart Video-Stylet Dispenser Box of 15 disposable video-stylets

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More Product Details

Catalog Number

S-SC-VS

Brand Name

Smart Video-Stylet

Version/Model Number

S-SC-VS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 28, 2120

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Device Record Status

Public Device Record Key

6435ab5d-153c-45d7-8153-2a9d3ad5e2db

Public Version Date

December 07, 2020

Public Version Number

1

DI Record Publish Date

November 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMART VIDEO-STYLET, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2