Venapax

Primary DI
M718VPX4000
Brand
Venapax
Company
SAPHENA MEDICAL, INC.
Model
VPX4000
Catalog number
VPX4000
Device description
The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneall or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external tothe parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.
Published
2024-06-06
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140603000ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETMSaphena Medical, Inc.2014-07-31GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M718VPX4000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, reusableA hand-held flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-31 Degrees Celsius62 Degrees Celsius
Storage Environment Humidity25 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-285-3517cblake@saphenamedical.com
904-741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
021317541
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M718VPX3000VenapaxVPX30002025-04-29

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Primary DI, Brand, Company table
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B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26