Duns Number:432448470
Device Description: SLIT LAMP SL 1000 REF 542-1255-001
Catalog Number
100209A50
Brand Name
ALCON
Version/Model Number
SLIT LAMP SL 1000
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,K992836
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
4efb1156-61a3-4151-a6ec-dc73b4645a64
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
August 03, 2016
Package DI Number
8056098470586
Quantity per Package
1
Contains DI Package
08056098470029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 37 |