Duns Number:480198725
Device Description: ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8
Catalog Number
-
Brand Name
ARveo 8
Version/Model Number
000000000010449063
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
EPT
Product Code Name
MICROSCOPE, SURGICAL
Public Device Record Key
c574bbdd-12df-4334-bf99-8fc961f77c5a
Public Version Date
October 18, 2021
Public Version Number
1
DI Record Publish Date
October 08, 2021
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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |