Duns Number:078375583
Device Description: Precision HD camera only for AUT & AUA series
Catalog Number
-
Brand Name
TV-3 Handle Camera Aurora 3 and Four Series
Version/Model Number
B1-715-56
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
KQM
Product Code Name
Camera, Surgical And Accessories
Public Device Record Key
28bd321a-a54f-475a-ae7b-c1bd08067f2d
Public Version Date
February 01, 2019
Public Version Number
1
DI Record Publish Date
January 01, 2019
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 | 747 |
2 | A medical device with a moderate to high risk that requires special controls. | 265 |