Duns Number:342228620
Device Description: This single use device is an accessory for ZEISS phaco systems. It has been designed to em This single use device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human cataract surgery.(consists of TEST CHAMBER, PHACO TIP and SILICONE SLEEVE).
Catalog Number
-
Brand Name
PHACO SET PLUS 21G,BICONICAL,30°
Version/Model Number
303060-1024-000
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
e077889d-00db-4af7-89c8-110fabc21b10
Public Version Date
May 03, 2022
Public Version Number
1
DI Record Publish Date
April 25, 2022
Package DI Number
04049539103888
Quantity per Package
10
Contains DI Package
04049539102508
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 |