FDA.reportPublic FDA data

Graftmaster

Primary DI
08717648176340
Brand
Graftmaster
Company
ABBOTT VASCULAR INC.
Model
1012580-16
Catalog number
1012580-16
Device description
GRAFTMASTER Coronary Stent Graft System 2.80 mm x 16 mm / Rapid-Exchange
Published
2014-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIVcoronary covered stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIVCoronary Covered StentUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648176340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648176340087176481763408717648176340

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal coronary artery stentA non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, dark, cool place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
964569052
Device count
1
DM exempt
false
Premarket exempt
false
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
08717648353765Esprit™Esprit™1212375-282025-07-12
08717648353666Esprit™Esprit™1212350-182025-07-10
08717648353680Esprit™Esprit™1212350-282025-07-10
08717648353703Esprit™Esprit™1212350-382025-07-10
08717648353741Esprit™Esprit™ 1212375-182025-07-10
08717648353789Esprit™Esprit™1212375-382025-07-10
08717648353826Esprit™Esprit™1212250-182025-07-10
08717648353840Esprit™Esprit™1212250-282025-07-10
08717648353864Esprit™Esprit™1212250-382025-07-10
08717648353987Esprit™Esprit™1212300-182025-07-10
08717648354007Esprit™Esprit™1212300-282025-07-10
08717648354021Esprit™Esprit™1212300-382025-07-10
08717648356704XACT™83024-0183024-012025-04-17
08717648356742XACT™ 83022-0183022-012025-04-17
08717648356766XACT™83020-0183020-012025-04-17
08717648356803XACT™83026-0183026-012025-04-17
08717648356810HI-TORQUE COMMAND™ 106000110600012024-11-21
08717648356827HI-TORQUE COMMAND™ 1060001A1060001A2024-11-21
08717648356834HI-TORQUE COMMAND™106000210600022024-11-21
08717648356841HI-TORQUE COMMAND™ 1060002A1060002A2024-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640130447158PK PapyrusBiotronik AGNIV2019-04-08
07640130447165PK PapyrusBiotronik AGNIV2019-04-08
07640130447172PK PapyrusBiotronik AGNIV2019-04-08
07640130447189PK PapyrusBiotronik AGNIV2019-04-08
07640130447196PK PapyrusBiotronik AGNIV2019-04-08
07640130447202PK PapyrusBiotronik AGNIV2019-04-08
07640130447219PK PapyrusBiotronik AGNIV2019-04-08
07640130447226PK PapyrusBiotronik AGNIV2019-04-08
07640130447233PK PapyrusBiotronik AGNIV2019-04-08
07640130447240PK PapyrusBiotronik AGNIV2019-04-08
07640130447257PK PapyrusBiotronik AGNIV2019-04-08
07640130447264PK PapyrusBiotronik AGNIV2019-04-08
07640130447271PK PapyrusBiotronik AGNIV2019-04-08
07640130447288PK PapyrusBiotronik AGNIV2019-04-08
07640130447295PK PapyrusBiotronik AGNIV2019-04-08
07640130447301PK PapyrusBiotronik AGNIV2019-04-08
07640130447318PK PapyrusBiotronik AGNIV2019-04-08
08717648176449GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176463GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176470GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176500GraftmasterABBOTT VASCULAR INC.NIV2014-11-21
08717648176524GraftmasterABBOTT VASCULAR INC.NIV2014-11-21