VIOLA

Primary DI
07290015460873
Brand
VIOLA
Company
VASCULAR GRAFT SOLUTIONS LTD
Model
17.0mm
Catalog number
FG087
Device description
CLAMPLESS PROXIMAL ANASTOMOSIS SEALING SYSTEM
Published
2023-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203307000
K230248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203307000VIOLAVascular Graft Solutions, Ltd.2021-02-17DXC
K230248000VIOLAVascular Graft Solutions, Ltd.2023-02-28DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015460873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015460873072900154608737290015460873

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular anastomosis occluderA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter17Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97235499054meital.y@graftsolutions.com

Regulatory Flags#

DUNS number
532829384
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015460866VIOLA15.0mmFG0862023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
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