FDA.report

SUPERA

Primary DI
08975370026412
Brand
SUPERA
Company
ABBOTT VASCULAR INC.
Model
S-45-030-120-P6
Catalog number
S-45-030-120-P6
Device description
Supera Peripheral Stent System 4.5 mm x 30 mm x 120 cm 6 F
Published
2015-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications

CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717648225901PrimaryGS10
08975370026412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717648225901087176482259018717648225901
08975370026412089753700264128975370026412

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from Direct Sunlight, Keep Dry

Sterilization Methods

Method

Contacts

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

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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

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