Duns Number:113503058
Device Description: Smart Video-Stylet Dispenser Box of 15 disposable video-stylets
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
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
CCW
Product Code Name
Laryngoscope, Rigid
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |