Duns Number:002348191
Device Description: OptiSphere, 5-pack, 600-800 micron, 2mL fill
Catalog Number
OSL268
Brand Name
OPTISPHERE
Version/Model Number
IPN913230
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
KRD
Product Code Name
Device, Vascular, for Promoting Embolization
Public Device Record Key
1d0ea7fc-6722-41a0-9376-e29204259cf8
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
March 27, 2018
Package DI Number
30841156100074
Quantity per Package
5
Contains DI Package
10841156100070
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |