Duns Number:480198725
Device Description: M320 Optics Carrier, Swing Arm, inclined C/W12 - for Leica surgical operating microscope s M320 Optics Carrier, Swing Arm, inclined C/W12 - for Leica surgical operating microscope systems: M320 W12, M320 C12, M320 LW12
Catalog Number
-
Brand Name
M320 Optics Carrier
Version/Model Number
000000000010448485
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
7e328567-baee-48ce-aa77-a8170917fadb
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 |