Duns Number:690635461
Device Description: The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patient The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.
Catalog Number
-
Brand Name
Slit Lamp
Version/Model Number
SL-2000
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
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
cd6ee053-b35d-4864-8ddb-36ff77dcd95e
Public Version Date
April 08, 2022
Public Version Number
3
DI Record Publish Date
July 03, 2017
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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |