Duns Number:480198725
Device Description: M530 Optics Carrier for IVA/Top Plate - for Leica surgical operating microscope systems: A M530 Optics Carrier for IVA/Top Plate - for Leica surgical operating microscope systems: ARveo, PROvido, M530 OHX, M530 OH6;
Catalog Number
-
Brand Name
M530 Optics Carrier
Version/Model Number
000000000010448700
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
87a950e5-51e5-4885-9217-d1cae7a5f242
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 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 |