FDA.reportPublic FDA data

S.M.A.R.T. RADIANZ

Primary DI
20705032082591
Brand
S.M.A.R.T. RADIANZ
Company
Cordis US Corp.
Model
SR07060XL
Catalog number
SR07060XL
Device description
S.M.A.R.T. RADIANZ Vascular Stent System 7x60mm 190CM
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIOSTENT, ILIAC
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIOStent, IliacUnknown3
NIPStent, Superficial Femoral ArteryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020036000
P120002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020036000S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEMCordis US Corporation2003-08-12NIO
P120002000SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMSCordis US Corporation2012-11-07NIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032082591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503208259120705032082591

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion; it might additionally be intended to be implanted in an obstructed biliary duct. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireC3515RSAC3515RSA2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireC3515RSSC3515RSS2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireC3515SSAC3515SSA2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireC3518RSAC3518RSA2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireC3518RSSC3518RSS2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireC3518SSAC3518SSA2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireC3526RSAC3526RSA2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireC3526SSAC3526SSA2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireC3526SSSC3526SSS2026-07-29
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100830VISTA BRITE TIP670-040-00M670-040-00M2024-09-09
10705032100892VISTA BRITE TIP778-034-00M778-034-00M2024-09-09
10705032100922VISTA BRITE TIP670-008-00M670-008-00M2024-09-09
10705032100953VISTA BRITE TIP778-270-00M778-270-00M2024-09-09
10862028000434MYNX CONTROLMX6760MX67602018-10-22
10862028000427MYNX CONTROLMX5060MX50602018-10-22
20705032036440Cordis PRECISE PRO Rx Nitinol Stent SystemPC0720RXCPC0720RXC2014-09-17
10705032009768AVANTI504405X504405X2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20705032082294S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082300S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082317S.M.A.R.T. RADIANZCORDIS CORPORATIONNIO2022-04-15
20705032082324S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082331S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082348S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082355S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
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
20705032082393S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082409S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082416S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082423S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082430S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082447S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082454S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082461S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082478S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082485S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082492S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082508S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082515S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082522S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082539S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082546S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082553S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082560S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082577S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15
20705032082584S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15