Duns Number:621134084
Device Description: Ultimate protection for femoral artery and radial access procedures. Unique shield design Ultimate protection for femoral artery and radial access procedures. Unique shield design protects hands, face and body. Will not inhibit the physicians technique. The small fenestration and the slit to the shield edge provide maximum protection to hands and body and excellent maneuverability around the sheath.
Catalog Number
-
Brand Name
SecureShield© Angiography 13" x 16" Scatter Reducing Drape
Version/Model Number
SS-5300
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPY
Product Code Name
Shield, Protective, Personnel
Public Device Record Key
1fae5312-897b-4cd7-a984-788f26d950b0
Public Version Date
September 06, 2022
Public Version Number
1
DI Record Publish Date
August 29, 2022
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 | 107 |