Duns Number:432448470
Device Description: SLIT LAMP SL9900 3X DIGITAL
Catalog Number
100257A30.D V0
Brand Name
S4 OPTIK
Version/Model Number
SL 9900 3X 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
f6aa42aa-ff1d-4fab-9d62-e194ac42b65d
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
September 30, 2016
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 |