AccessGUDID - DEVICE: VASCU-GUARD Peripheral Vascular Patch (00085412530871)

GUDID

Device Identifier (DI) Information

Brand Name: VASCU-GUARD Peripheral Vascular Patch
Version or Model: VG0106N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VG0106N
Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.

Primary DI Number: 00085412530871
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017415781 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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Product Code	Product Code Name
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: more than 0 Degrees Celsius
Special Storage Condition, Specify: Do not freeze.Store at room temperature.
Storage Environment Temperature: more than 32 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 326304e2-3900-4369-84f1-e39a95ffafdc
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: October 08, 2015