FDA.reportPublic FDA data

SCANLAN® A/C Locator® graft marker

Primary DI
10846159001034
Brand
SCANLAN® A/C Locator® graft marker
Company
SCANLAN INTERNATIONAL INC
Model
1001-83
Catalog number
1001-83
Device description
U-shaped style, silicone (1 per sterile pkg)
Published
2015-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
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
10846159001034PackageGS110In Commercial Distribution
00846159001037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084615900103410846159001034
00846159001037008461590010378461590010370846159001037

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

Contacts#

Phone, Email table
PhoneEmail
6512980997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10846159001041Scanlan® RADIOMARK® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27
00846159025644Scanlan® RADIOMARK® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27
00846159025651Scanlan® A/C LOCATOR® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27