Duns Number:480198725
Device Description: C40 Ceiling swingarm for M844 / M822 - for Leica surgical operating microscope systems: M8 C40 Ceiling swingarm for M844 / M822 - for Leica surgical operating microscope systems: M822 C40, M822 CT40, M844 C40, M844 CT40
Catalog Number
-
Brand Name
M822 C40 / M822 CT40 / M844 C40 / M844 CT40
Version/Model Number
000000000010448140
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
FSO
Product Code Name
MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
529f7f9e-7f80-440c-ad08-88a81d41a78b
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 |