Duns Number:103021940
Device Description: OPO73 FUSION DUAL PUMP PACK
Catalog Number
OPO73
Brand Name
WHITESTAR SIGNATURE
Version/Model Number
OPO73
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
-
Product Code
HQC
Product Code Name
Unit, phacofragmentation
Public Device Record Key
e8bd9022-5886-4fda-ba34-4ac862c614cd
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
September 02, 2016
Package DI Number
05050474602083
Quantity per Package
6
Contains DI Package
15050474602080
Package Discontinue Date
-
Package Status
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 |