Duns Number:042075700
Device Description: The ClampEase FAPD-OT Disc is a femoral artery oval tunnel pressure disc with a TAPER atta The ClampEase FAPD-OT Disc is a femoral artery oval tunnel pressure disc with a TAPER attach.
Catalog Number
150-2012-24a
Brand Name
ClampEase Disc
Version/Model Number
FAPD-OT
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
K964663,K964663,K964663
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
3df8d5aa-21f3-4694-b4ff-4dd1127bdae8
Public Version Date
June 02, 2022
Public Version Number
1
DI Record Publish Date
May 25, 2022
Package DI Number
20815614021020
Quantity per Package
24
Contains DI Package
10815614021023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| 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 |