Duns Number:969792050
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
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
CCW
Product Code Name
Laryngoscope, Rigid
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
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
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 |