FDA.reportPublic FDA data

Herculink Elite

Primary DI
08717648078019
Brand
Herculink Elite
Company
ABBOTT VASCULAR INC.
Model
1011493-15
Catalog number
1011493-15
Device description
RX Herculink Elite Renal and Biliary Stent System 5.0 mm x 15 mm x 135 cm
Published
2014-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NINSTENT, RENAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NINStent, RenalUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648078019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648078019087176480780198717648078019

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08717648077791Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077807Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077814Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077821Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077838Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077845Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077883Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077890Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077906Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077913Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077920Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077937Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077975Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077982Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648077999Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078002Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078026Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078064Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078071Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078088Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078095Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078101Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078118Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078156Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078163Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078170Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078187Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078194Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078200Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21
08717648078248Herculink EliteABBOTT VASCULAR INC.NIN2014-11-21