FDA.reportPublic FDA data

SCANLAN® A/C Locator® graft marker

Primary DI
00846159001037
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
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

Contacts#

Phone, Email table
PhoneEmail
6512980997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159010978SCANLAN® In Situ Valvulotomes9009-1219009-1212016-09-02
00846159010985SCANLAN® In Situ Valvulotomes9009-1229009-1222016-09-02
00846159010992SCANLAN® In Situ Valvulotomes9009-1239009-1232016-09-02
00846159031997SCANLAN® In Situ Valvulotomes9009-1249009-1242016-09-02
00846159032000SCANLAN® In Situ Valvulotomes9009-1259009-1252016-09-02
00846159036411SCANLAN® Clamp3785-443785-442026-09-21
00846159036428SCANLAN® Clamp3786-443786-442026-09-21
00846159040845SCANLAN® ScissorsQ32034Q320342026-08-26
00846159040852SCANLAN® ScissorsQ32035Q320352026-08-26
00846159040869SCANLAN® ScissorsQ32046Q320462026-08-26
00846159040678SCANLAN® Minimally-Invasive InstrumentationQ29142-9Q29142-92026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationQ29150-9Q29150-92026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationQ29163-9Q29163-92026-07-17
00846159040708SCANLAN®9009-941P9009-941P2026-07-17
00846159036152SCANLAN® Bulldog Clamp3795-453795-452026-06-23
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

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
10846159001034SCANLAN® 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