Duns Number:042075700
Device Description: The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure dis The ClampEase P-Series P-700 Disc is a femoral artery medium race-track shape pressure disc with a BALL attach.
Catalog Number
150-2031-70
Brand Name
ClampEase P-Series Disc
Version/Model Number
P-700
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
K863427,K863427,K863427
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
c85099ff-fc4f-471a-8d12-f65e18cf8af3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
30815614020358
Quantity per Package
15
Contains DI Package
20815614020351
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |