Duns Number:229053087
Device Description: Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS
Catalog Number
73281088/10SA
Brand Name
Gelweave™
Version/Model Number
73281088/10SA
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
K090987
Product Code
DSY
Product Code Name
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Public Device Record Key
cc0f56df-9fe8-482c-a483-7888a40ffaf7
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 |