Duns Number:341325716
Device Description: Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and hig Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher).Kit consists of Patient Interface and Suction Clip 125.
Catalog Number
90000200TPV
Brand Name
VICTUS VERAFIT Patient Interface Kit
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
ed73ca1f-e7e8-4715-9a58-472c012468b7
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
December 05, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |