Duns Number:432448470
Device Description: SLIT LAMP SL990 5X DIGITAL
Catalog Number
100257A50.D V0
Brand Name
S4 OPTIK
Version/Model Number
SL 990 5X LED digital
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
K992836
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
eceece3a-c2e9-4b7a-9084-84638cc59298
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
December 10, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 37 |