FDA.reportPublic FDA data

Scanlan® RADIOMARK® graft markers

Primary DI
00846159025644
Brand
Scanlan® RADIOMARK® graft markers
Company
SCANLAN INTERNATIONAL INC
Model
1001-831B
Catalog number
1001-831B
Device description
Disk-shaped style, silicone, bulk NS, 10 per pk
Published
2015-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MABMarker, Cardiopulmonary Bypass (Vein Marker)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MABMarker, Cardiopulmonary Bypass (Vein Marker)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159025644PrimaryGS10
00846159029444Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159025644008461590256448461590256440846159025644
00846159029444008461590294448461590294440846159029444

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

Contacts#

Phone, Email table
PhoneEmail
651 298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159036404SCANLAN® Bulldog Clamp3795-553795-552026-06-09
00846159040524SCANLAN® Retractor8008-568008-562026-06-04
00846159040531SCANLAN® Retractor8008-598008-592026-06-04
00846159040548SCANLAN® Retractor8008-608008-602026-06-04
00846159040555SCANLAN® Retractor8888-058888-052026-06-04
00846159040562SCANLAN® Retractor8888-588888-582026-06-04
00846159040579SCANLAN® Retractor8989-188989-182026-06-04
00846159040586SCANLAN® RetractorQ195Q1952026-06-04
00846159040593SCANLAN® RetractorQ219Q2192026-06-04
00846159040609SCANLAN® RetractorQ222Q2222026-06-04
00846159040616SCANLAN® RetractorQ28124-38-2NQ28124-38-2N2026-06-04
00846159040623SCANLAN® RetractorQ28124-38-3NQ28124-38-3N2026-06-04
00846159040388SCANLAN® Retractor8008-1828008-1822026-06-03
00846159040395SCANLAN® Retractor8008-2008008-2002026-06-03
00846159040401SCANLAN® Retractor8008-2028008-2022026-06-03
00846159040418SCANLAN® Retractor8008-2048008-2042026-06-03
00846159040425SCANLAN® Retractor8008-24-18008-24-12026-06-03
00846159040432SCANLAN® Retractor8008-268008-262026-06-03
00846159040449SCANLAN® Retractor8008-26-18008-26-12026-06-03
00846159040456SCANLAN® Retractor8008-26-28008-26-22026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B776106961Coronary Bypass MarkerFIRST CALL, INC.MAB2019-10-03
04026704523054PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523061PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523078PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523085PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523058PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523065PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523072PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523089PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
00846159001037SCANLAN® A/C Locator® graft markerSCANLAN INTERNATIONAL INCMAB2015-08-28
10846159001034SCANLAN® A/C Locator® graft markerSCANLAN INTERNATIONAL INCMAB2015-08-28
10846159001041Scanlan® RADIOMARK® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27
00846159025651Scanlan® A/C LOCATOR® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27