Duns Number:184805166
Device Description: AlboGraft® Knitted with Collagen 18mm x 40cm
Catalog Number
AMC4018
Brand Name
AlboGraft Polyester Vascular Graft
Version/Model Number
AMC4018
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"
-
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
-
Product Code
MAL
Product Code Name
Graft, Vascular, Synthetic/Biologic Composite
Public Device Record Key
a5ba0eb0-d51a-4af6-bbfb-fdc970242138
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 18, 2021
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |
| 3 | A medical device with high risk that requires premarket approval | 22 |