Duns Number:785335381
Device Description: Revelation lll Microscope; monocular, achromat objectives, auto switching
Catalog Number
R3M-MN4A-DAL3
Brand Name
LW Scientific, Inc.
Version/Model Number
R3M-MN4A-DAL3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2022
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
IBJ
Product Code Name
Light, Microscope
Public Device Record Key
777ea195-edd0-4a47-b605-ef48580713a1
Public Version Date
September 08, 2022
Public Version Number
2
DI Record Publish Date
April 09, 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 | 94 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |