Flouropassiv™

Basic Information

• Brand Name: Flouropassiv™
• Primary DI: 05037881011035
• Version / Model: 921050FT
• Catalog Number: 921050FT
• Company Name: VASCUTEK LTD
• Labeler DUNS: 229053087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 6
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 779e0d72-14bd-4d64-89ee-9395b59ce622
• Distribution End Date: 2019-11-30

Device Description

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE	Cardiovascular	870.3470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05037881011035	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Dimension 10 x 50 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.