Duns Number:078340058
Device Description: 5mm ID x 35cm Length exGraft Carbon ePTFE Vascular Graft
Catalog Number
RUC053501
Brand Name
exGraft Carbon
Version/Model Number
RGC053501
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K183613,K183613
Product Code
DSY
Product Code Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Public Device Record Key
c0f688c2-024c-4807-890a-18744dcc4802
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
August 12, 2019
Package DI Number
00818136022984
Quantity per Package
1
Contains DI Package
00818136022588
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer/Shipper Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 19 |