Duns Number:482661753
Device Description: OVB1 HD Camera Control Unit Contents also include: (1) Power Cable, (1) USB Flash Drive, ( OVB1 HD Camera Control Unit Contents also include: (1) Power Cable, (1) USB Flash Drive, (1) Video Cable DVI-D to DVI-D, 1m, (1) Video Cable DVI-D to DVI-D, 3m, (1) Video Cable HD SDI, 12 ft, (2) Remote Cable, 3.5mm, 3 ft
Catalog Number
242300
Brand Name
NA
Version/Model Number
242300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 2021
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
FWF
Product Code Name
CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO
Public Device Record Key
877a89ea-b0d3-44e0-9963-91134c40bcb1
Public Version Date
January 28, 2021
Public Version Number
6
DI Record Publish Date
January 30, 2016
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |