Duns Number:042075700
Device Description: The ClampEase mechanical compression device provides a hands-free approach for hemostasis The ClampEase mechanical compression device provides a hands-free approach for hemostasis following femoral artery catheterization procedures. The ClampEase Stystem is comprised of a durable ClampEase Stand and a sterile, disposable ball or taper style Disc. The Model C-700 ClampEase System is compatible with those styles of Discs that are designed for Ball Tip Attachment.
Catalog Number
160-2010-00
Brand Name
ClampEase Vascular Compression Device
Version/Model Number
C-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"
-
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
K964662
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
10ad1cab-8f18-4c09-96aa-f946cab91283
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |