Duns Number:527884077
Device Description: Operation microscope used for observation of surgical and other medical procedures,consist Operation microscope used for observation of surgical and other medical procedures,consisting of an optical system of observation,including objective lens,variable or fixed power optical system,observation tube and eyepieces.
Catalog Number
-
Brand Name
Mediworks
Version/Model Number
SM610
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRM
Product Code Name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Public Device Record Key
cb4e077e-969a-4d4b-a4ae-5b8acbfa2384
Public Version Date
September 23, 2019
Public Version Number
1
DI Record Publish Date
September 15, 2019
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |