DEVICE: Hemacarotid Patch (00384401001478)
Device Identifier (DI) Information
Hemacarotid Patch
HEK08/75CPUT (1)
In Commercial Distribution
HEK08/75CPUT (1)
INTERVASCULAR SAS
HEK08/75CPUT (1)
In Commercial Distribution
HEK08/75CPUT (1)
INTERVASCULAR SAS
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35273 | Cardiovascular patch, animal-derived |
An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K983819 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room Temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 8 Millimeter |
Length: 75 Millimeter |
Device Record Status
d18a1f1a-c32b-4eff-99ba-0d9ba26803c9
February 05, 2021
4
September 24, 2015
February 05, 2021
4
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+33442084646
cardiovascular.vics@getinge.com
cardiovascular.vics@getinge.com