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Viola

FDA UDI

Class II (US FDA UDI)

by Vascular Graft Solutions, Ltd.

Identity

Trade Name
VIOLA FDA UDI
Generic Name
Intravascular anastomosis occluder FDA UDI
Device Name
CLAMPLESS PROXIMAL ANASTOMOSIS SEALING SYSTEM FDA UDI
Model / Reference
17.0mm FDA UDI
Description
CLAMPLESS PROXIMAL ANASTOMOSIS SEALING SYSTEM FDA UDI

Identifiers

Catalog Number
FG087 FDA UDI
Primary DI / UDI-DI
07290015460873 FDA UDI
510(k) Number
K203307 FDA UDI
K230248 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Intravascular anastomosis occluder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 17 Millimeter FDA UDI

Category: Intravascular anastomosis occluder

Viola by Vascular Graft Solutions, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular anastomosis occluder.

Cleared under the same submission

K203307 also covers:

K230248 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vascular Graft Solutions, Ltd.

Sources (1)

  • FDA UDI 51a3b6be-6daf-459c-ac2e-5c74a9c08b2f 37 fields · synced May 30, 2026