Duns Number:081712583
Device Description: ENDOVUE PLUS 4K 32", QUAD-LINK SDI, CHINA, BC-WK32-A1B20
Catalog Number
-
Brand Name
EndoVue
Version/Model Number
90K0098
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 11, 2022
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
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
KQM
Product Code Name
Camera, Surgical And Accessories
Public Device Record Key
4957f26a-e600-4841-bd78-3c66d1aefe1c
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
July 11, 2022
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 | 194 |
2 | A medical device with a moderate to high risk that requires special controls. | 147 |