Duns Number:149818952
Device Description: Femoral Compression System
Catalog Number
C11165
Brand Name
FemoStop™
Version/Model Number
Gold
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"
Yes
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
K110193,K110193
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
c89b5a13-26b5-4d36-b55e-a55468bc37f5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 19, 2016
Package DI Number
15414734050033
Quantity per Package
10
Contains DI Package
05414734050036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |