Duns Number:382174019
Device Description: Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Siz Hemashield Platinum Woven 4 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Accessory
Catalog Number
M00202175922P0
Brand Name
Hemashield
Version/Model Number
M00202175922P0
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
9b129cbf-e6b4-45d1-af6c-2f94b782be72
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
November 09, 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 |