FDA.reportPublic FDA data

SUPERA

Primary DI
08717648211768
Brand
SUPERA
Company
ABBOTT VASCULAR INC.
Model
S-50-100-120-P6
Catalog number
S-50-100-120-P6
Device description
Supera Peripheral Stent System 5 mm x 100 mm x 120 cm 6 F
Published
2015-12-11
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
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648211768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648211768087176482117688717648211768

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, Specify00Keep away from Direct Sunlight, Keep Dry

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
00827002037960Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002037977Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002037991Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038004Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038011Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038028Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182370Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182387Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182394Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182417Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182431Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182448Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182455Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182462Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182479Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182493Zilver FlexCOOK IRELAND LTDNIP2025-12-04
20705032082331S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082362S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082379S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082386S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082409S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082423S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082447S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082485S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082508S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082553S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082584S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082614S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082652S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
00733132645725GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16