POWERFLEX

Primary DI
20705032060155
Brand
POWERFLEX
Company
Cordis US Corp.
Model
4401203S
Catalog number
4401203S
Device description
POWERFLEXPRO 12MM3CM 80
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112797000POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERCordis Corp.2012-05-04LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032060155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503206015520705032060155

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damanged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000086RAIN Sheath® Tibial Pedal IntroducerTP506410NTP506410N2023-05-05
10705032000093RAIN Sheath® Tibial Pedal IntroducerTP506410STP506410S2023-05-05
10705032078894RAIN Sheath Transradial506616H506616H2018-10-09
10705032078924RAIN Sheath Transradial506716H506716H2018-10-09
10705032078931RAIN Sheath Transradial506416S506416S2018-10-09
10705032078948RAIN Sheath Transradial506610S506610S2018-10-09
10705032078955RAIN Sheath Transradial506710S506710S2018-10-09
10705032078962RAIN Sheath Transradial506410H506410H2018-10-09
10705032078979RAIN Sheath Transradial506510H506510H2018-10-09
10705032078986RAIN Sheath Transradial506716S506716S2018-10-09
10705032078993RAIN Sheath Transradial506416H506416H2018-10-09
10705032079006RAIN Sheath Transradial506616S506616S2018-10-09
10705032079013RAIN Sheath Transradial506710H506710H2018-10-09
10705032079037RAIN Sheath Transradial506610H506610H2018-10-09
10705032082068RAIN Sheath Transradial506410P20G506410P20G2020-12-17
10705032082075RAIN Sheath Transradial506716P22G506716P22G2020-12-17
10705032082082RAIN Sheath Transradial506616P22G506616P22G2020-12-17
10705032082105RAIN Sheath Transradial506510P22G506510P22G2020-12-17
10705032082112RAIN Sheath Transradial506510P20G506510P20G2020-12-17
10705032082129RAIN Sheath Transradial506516N506516N2020-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489069334NAMICMEDLINE INDUSTRIES, INC.LIT2021-10-28
10193489069341NAMICMEDLINE INDUSTRIES, INC.LIT2021-07-26
20193489087793MedlineMEDLINE INDUSTRIES, INC.LIT2021-05-12
H965800450750NAMICANGIODYNAMICS, INC.LIT2020-11-03
00643169843059Stretch™ Insertion ToolMEDTRONIC, INC.LIT2018-07-06
H965914003000NAMICNAVILYST MEDICAL, INC.LIT2016-09-21
H965914004000NAMICNAVILYST MEDICAL, INC.LIT2016-09-21
00643169002913Stretch™ Insertion ToolMEDTRONIC, INC.LIT2016-07-02
08033477048772REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048802REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048833REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048864REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048888REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048925REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048956REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048987REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049014REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049045REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049069REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049076REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049106REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049137REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049168REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049199REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049212REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049229REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049250REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049281REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049311REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049373REEF HPMEDTRONIC, INC.LIT2016-06-19