Duns Number:103021940
Device Description: WHITESTAR SILICONE IRRIGATION TUBING 6PK
Catalog Number
690699
Brand Name
WHITESTAR PHACO HANDPIECE
Version/Model Number
690699
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 19, 2018
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
KYG
Product Code Name
DEVICE, IRRIGATION, OCULAR SURGERY
Public Device Record Key
b4e830b6-bc86-451b-9439-54c0c9e09cfd
Public Version Date
February 26, 2020
Public Version Number
4
DI Record Publish Date
September 02, 2016
Package DI Number
15050474508061
Quantity per Package
6
Contains DI Package
05050474508064
Package Discontinue Date
September 19, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |