Duns Number:023055619
Device Description: Dennis Femoral Artery Clamp
Catalog Number
2002-59
Brand Name
SCANLAN®
Version/Model Number
2002-59
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
-
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
e68fb987-30a5-4f5a-a54a-bb69a0345448
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 21, 2015
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 | 1949 |
2 | A medical device with a moderate to high risk that requires special controls. | 855 |