VIOLA

Basic Information

• Brand Name: VIOLA
• Primary DI: 07290015460873
• Version / Model: 17.0mm
• Catalog Number: FG087
• Company Name: VASCULAR GRAFT SOLUTIONS LTD
• Labeler DUNS: 532829384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-15
• Public Version: 3
• Public Version Date: 2023-03-09
• Public Version Status: Update
• Public Device Record Key: 51a3b6be-6daf-459c-ac2e-5c74a9c08b2f

Device Description

CLAMPLESS PROXIMAL ANASTOMOSIS SEALING SYSTEM

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47110	Intravascular anastomosis occluder	A device designed to temporarily occlude the flow of blood in the lumen of a blood vessel at a vascular anastomosis, primarily to control bleeding and enable operative field visualization during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a flexible shaft with dilated/bulbous ends that is entirely inserted into the vessel lumen via a small incision at the surgical site to arrest blood flow at the anastomosis; it will typically have an external tab or tether used for its removal. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290015460873	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K203307	000
K230248	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	17	Millimeter