Duns Number:010130626
Device Description: LIQUID OPTICS INTERFACE, SIZE 12, GEN2
Catalog Number
0180-1201
Brand Name
LIQUID OPTICS INTERFACE
Version/Model Number
0180-1201
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
Yes
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
OOE
Product Code Name
Ophthalmic femtosecond laser
Public Device Record Key
a9f3f82f-80ca-4dba-9a7f-404faf6cadd7
Public Version Date
October 26, 2020
Public Version Number
4
DI Record Publish Date
June 08, 2018
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 | 42 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
3 | A medical device with high risk that requires premarket approval | 3950 |