VASCU-GUARD Peripheral Vascular Patch - Vascu-Guard is prepared from bovine pericardium - SYNOVIS LIFE TECHNOLOGIES, INC.

Duns Number:017415781

Device Description: Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Vascu-Guard is chemically sterilized using ethanol and propylene oxide. Vascu-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25C. Vascu-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile

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More Product Details

Catalog Number

VG0209N

Brand Name

VASCU-GUARD Peripheral Vascular Patch

Version/Model Number

VG0209N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Record Status

Public Device Record Key

3e79a953-40ca-4910-af71-cf052f080de3

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

October 08, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNOVIS LIFE TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 135