Duns Number:042075700
Device Description: The CompressAR 3-FingerJack Disc is a sterile, single use product that is attached to the The CompressAR 3-FingerJack Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The 3-FinigerJack disc has a unique shape. It is approximately 1.875" long and 1.5 " wide.
Catalog Number
150-0301-06
Brand Name
CompressAR 3-FingerJack Disc
Version/Model Number
5301
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
K002767,K002767,K002767
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
41dbcefe-a648-4b10-b878-27812440bc50
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20815614020221
Quantity per Package
12
Contains DI Package
10815614020224
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |