Duns Number:229053087
Device Description: Gelseal Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM LEFT BRANCH
Catalog Number
461010
Brand Name
Gelseal™
Version/Model Number
461010
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"
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
P890045
Product Code
MAL
Product Code Name
GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Public Device Record Key
54229b9f-8d7d-40bf-bc0a-b50bcf072d23
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1682 |
| 3 | A medical device with high risk that requires premarket approval | 40 |