Duns Number:103021940
Device Description: VERITAS SWIVEL PHACO HANDPIECE SYSTEM
Catalog Number
VRT691027
Brand Name
VERITAS SWIVEL PHACO HANDPIECE SYSTEM
Version/Model Number
VRT691027
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQC
Product Code Name
Unit, phacofragmentation
Public Device Record Key
d080c655-5c45-46ba-acef-a66456d3af30
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 16, 2021
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 |