DEVICE: Vascu-Guard (00085412818634)
Device Identifier (DI) Information
Vascu-Guard
VG02515
In Commercial Distribution
VG02515
SYNOVIS LIFE TECHNOLOGIES, INC.
VG02515
In Commercial Distribution
VG02515
SYNOVIS LIFE TECHNOLOGIES, INC.
VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PSQ | Intracardiac Patch Or Pledget, Biologically Derived |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K221032 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 20 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
f5793537-9c54-45f0-aaa7-960531e6689c
December 06, 2022
1
November 28, 2022
December 06, 2022
1
November 28, 2022
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
[?]
+1 800-933-0303
medinfo_medproducts@baxter.com
medinfo_medproducts@baxter.com