Duns Number:480198725
Device Description: M320 Optics Carrier incl. Swing arm - for Leica surgical operating microscope systems: M32 M320 Optics Carrier incl. Swing arm - for Leica surgical operating microscope systems: M320 FP12, M320 F12, M320 TP12, M320 LW12, M320 TC12
Catalog Number
-
Brand Name
M320 Optics Carrier
Version/Model Number
000000000010448419
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
88af0a66-bd64-4083-bfc5-a4b572547192
Public Version Date
June 30, 2021
Public Version Number
1
DI Record Publish Date
June 22, 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 |