Duns Number:342228620
Device Description: The Product is a single use sterile accessory kit for the ZEISS phaco and vitreoretinal sy
Catalog Number
-
Brand Name
QUATTRO CASSETTE
Version/Model Number
303061-9015-000
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
K212241,K212241
Product Code
HQC
Product Code Name
Unit, Phacofragmentation
Public Device Record Key
5d86bddf-8d19-4814-acae-49ca47676872
Public Version Date
May 03, 2022
Public Version Number
1
DI Record Publish Date
April 25, 2022
Package DI Number
04049539104533
Quantity per Package
8
Contains DI Package
04049539104526
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| 3 | A medical device with high risk that requires premarket approval | 1 |