Duns Number:382174019
Device Description: Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accesso Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
Catalog Number
M00202166147P0
Brand Name
Hemashield
Version/Model Number
M00202166147P0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K021213
Product Code
MAL
Product Code Name
Graft, Vascular, Synthetic/Biologic Composite
Public Device Record Key
f9dbf180-5e1e-46c6-9617-99ed277eefad
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
November 10, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 397 |