Safe-Cam Sterile Video Stylet - BIOTEX, INC.

Duns Number:969792050

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More Product Details

Catalog Number

SC-VS

Brand Name

Safe-Cam Sterile Video Stylet

Version/Model Number

033-1000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 17, 2020

Issuing Agency

In HIBCC

Product Characteristics

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

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

a5ec0fe6-95b9-492c-afc0-10d64a69207e

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

July 25, 2018

Additional Identifiers

Package DI Number

M710SCVS2

Quantity per Package

15

Contains DI Package

M710SCVS0

Package Discontinue Date

February 17, 2020

Package Status

Not in Commercial Distribution

Package Type

Dispenser Box

"BIOTEX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 2