Vascu-Guard VG0106
GUDID 00085412818474
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.
SYNOVIS LIFE TECHNOLOGIES, INC.
Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived| Primary Device ID | 00085412818474 |
| NIH Device Record Key | fbda564c-5acb-4f94-96f0-4ffad6a58937 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vascu-Guard |
| Version Model Number | VG0106 |
| Catalog Number | VG0106 |
| Company DUNS | 017415781 |
| Company Name | SYNOVIS LIFE TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412818474 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221032
FDA Product Code
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-06 |
| Device Publish Date | 2022-11-28 |
On-Brand Devices [Vascu-Guard]
| 00085412818634 | VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi |
| 00085412818573 | VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi |
| 00085412818559 | VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi |
| 00085412818535 | VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi |
| 00085412818511 | VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi |
| 00085412818498 | VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi |
| 00085412818474 | VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated wi |
Trademark Results [Vascu-Guard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VASCU-GUARD 86072412 4765157 Live/Registered |
Synovis Life Technologies, Inc. 2013-09-23 |
 VASCU-GUARD 74518571 1898781 Live/Registered |
SYNOVIS LIFE TECHNOLOGIES, INC. 1994-04-29 |
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