Duns Number:103021940
Device Description: SOVEREIGN COMPACT REUSABLE 5-PACK
Catalog Number
OPO65
Brand Name
SOVEREIGN COMPACT
Version/Model Number
OPO65
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
-
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
3b24da32-654a-49d1-a5d0-24bcee98ca7c
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
September 02, 2016
Package DI Number
15050474520933
Quantity per Package
5
Contains DI Package
05050474520936
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 |