DEVICE: Gelsoft™ Cardiovascular Patch (05037881010663)
Device Identifier (DI) Information
Gelsoft™ Cardiovascular Patch
961001S
In Commercial Distribution
961001S
VASCUTEK LTD
961001S
In Commercial Distribution
961001S
VASCUTEK LTD
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
Device Characteristics
Labeling does not contain MRI Safety Information | |
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 [?] |
---|---|
K200955 | 000 |
K963611 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be implanted within one month after removal from the foil pouch. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Dimensions 10 x 1 cm |
Device Record Status
ab3c1e64-4d70-4cc7-9319-416438b627f1
February 05, 2021
2
July 16, 2020
February 05, 2021
2
July 16, 2020
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
[?]
+1(800)888-3786
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com