DEVICE: Hemashield (00384401017875)
Device Identifier (DI) Information
Hemashield
M002000195290
In Commercial Distribution
M002000195290
INTERVASCULAR SAS
M002000195290
In Commercial Distribution
M002000195290
INTERVASCULAR SAS
Hemashield Knitted Double Velour Cardiovascular Fabric
Device Characteristics
MR Safe | |
No | |
Yes | |
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 |
---|---|
DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K955349 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Controlled Room Temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 7.6 Centimeter |
Width: 0.8 Centimeter |
Device Record Status
cfaee2de-374c-4829-9f1c-c37c0e13949e
February 05, 2021
4
November 11, 2015
February 05, 2021
4
November 11, 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