Duns Number:013486803
Device Description: Low Turbulence Small Incision Phaco Needle Pack 20Ga, 30°Includes: Infusion Sleeve, Test C Low Turbulence Small Incision Phaco Needle Pack 20Ga, 30°Includes: Infusion Sleeve, Test Chamber and Wrench
Catalog Number
5005
Brand Name
NA
Version/Model Number
NA
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
K950880,K950880
Product Code
HQC
Product Code Name
Unit, Phacofragmentation
Public Device Record Key
130022d3-2c83-40bb-8840-d06a977322a4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 17, 2018
Package DI Number
30818255010047
Quantity per Package
5
Contains DI Package
10818255010043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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. | 35 |