Duns Number:229053087
Device Description: Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis AX-BIFEM ERS REINFORCED
Catalog Number
690808PFS
Brand Name
Gelsoft Plus™
Version/Model Number
690808PFS
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
K034010
Product Code
DSY
Product Code Name
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Public Device Record Key
670bc11c-4eac-4382-b077-2b6d3a1041d2
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 22, 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 |