Duns Number:480198725
Device Description: F12 Floor Stand for M320 - for Leica surgical operating microscope system: M320 F12
Catalog Number
-
Brand Name
M320 F12
Version/Model Number
000000000010448434
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
e0d8d025-abea-4927-8619-0f060680aacb
Public Version Date
July 07, 2021
Public Version Number
1
DI Record Publish Date
June 29, 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 |