Duns Number:078807493
Device Description: For Visum LED
Catalog Number
P45000
Brand Name
StrykeCam
Version/Model Number
P45000
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)
-
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
40af2939-dd08-42ec-b447-d9a34823edfc
Public Version Date
March 09, 2020
Public Version Number
1
DI Record Publish Date
February 28, 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 | 44 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |