Duns Number:017415781
Device Description: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber b Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a T configuration. Flo-Rester bulbs and tab are radiopaque.
Catalog Number
50400
Brand Name
Flo-Rester® Disposable Internal Vessel Occluder
Version/Model Number
50400
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
K883696,K883696
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
3dd55154-a3d8-41fd-8a93-d07b68defb98
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50085412532009
Quantity per Package
5
Contains DI Package
00085412532004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |