FDA.reportPublic FDA data

Graftmaster

Primary DI
08717648176449
Brand
Graftmaster
Company
ABBOTT VASCULAR INC.
Model
1012582-16
Catalog number
1012582-16
Device description
GRAFTMASTER Coronary Stent Graft System 4.00 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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYGCATHETER, FLOW DIRECTED
MAFSTENT, CORONARY
NIVcoronary covered stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2
MAFStent, CoronaryUnknown3
NIVCoronary Covered StentUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648176449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648176449087176481764498717648176449

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648175060StarClose SE™ 14679-0514679-052014-11-21
08717648000621Prostar™ 12322-0112322-012014-11-21
08717648199059XIENCE ALPINE1125225-081125225-082014-11-21
08717648199066XIENCE ALPINE1125225-121125225-122014-11-21
08717648199073XIENCE ALPINE1125225-151125225-152014-11-21
08717648199080XIENCE ALPINE1125225-181125225-182014-11-21
08717648199097XIENCE ALPINE1125225-231125225-232014-11-21
08717648199103XIENCE ALPINE1125225-281125225-282014-11-21
08717648199141XIENCE ALPINE1125250-081125250-082014-11-21
08717648199158XIENCE ALPINE1125250-121125250-122014-11-21
08717648199165XIENCE ALPINE1125250-151125250-152014-11-21
08717648199172XIENCE ALPINE1125250-181125250-182014-11-21
08717648199189XIENCE ALPINE1125250-231125250-232014-11-21
08717648199196XIENCE ALPINE1125250-281125250-282014-11-21
08717648199202XIENCE ALPINE1125250-331125250-332014-11-21
08717648199219XIENCE ALPINE1125250-381125250-382014-11-21
08717648199233XIENCE ALPINE1125275-081125275-082014-11-21
08717648199240XIENCE ALPINE1125275-121125275-122014-11-21
08717648199257XIENCE ALPINE1125275-151125275-152014-11-21
08717648199264XIENCE ALPINE1125275-181125275-182014-11-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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