Voss Non-Sterile Coronary Bypass Graft Marker

Primary DI
00811304020072
Brand
Voss Non-Sterile Coronary Bypass Graft Marker
Company
VM CARDIO VASCULAR, INC.
Model
40149-NS
Device description
Coronary Bypass Graft Marker-Non-sterile
Published
2016-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KPKMarker, Ostia, Aorto-Saphenous Vein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPKMarker, Ostia, Aorto-Saphenous VeinGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895369000VOSS GRAFT MARKERVoss Medical Products1989-09-27KPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811304020072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811304020072008113040200728113040200720811304020072

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric coronary bypass markerA sterile device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a synthetic polymer ring (e.g., silicone) impregnated with a metal [e.g., tungsten (W)] to aid visualization, and is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy]. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
799240457
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811304020041Voss Coronary Bypass Sterile Marker401492016-01-05
00811304020065Voss Coronary Bypass Vein Flushing Cannula826092016-01-05
00811304020096Voss Coronary Bypass Vein Flushing Cannula82609-NS2016-01-05
00811304020058Voss Coronary Bypass Vein Clamp829312016-01-05
00811304020089Voss Coronary Bypass Vein Clamp82931-NS2016-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811304020041Voss Coronary Bypass Sterile MarkerVM CARDIO VASCULAR, INC.KPK2016-01-05