Duns Number:480198725
Device Description: PROVEO Optics Carrier - for Leica surgical operating microscope systems: PROVEO 8
Catalog Number
-
Brand Name
PROVEO 8 Optics Carrier
Version/Model Number
000000000010448800
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
HRM
Product Code Name
MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
Public Device Record Key
1ecc5492-3621-48e2-9d2d-29a20b4f0ab3
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
September 22, 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |