FDA.reportPublic FDA data

S.M.A.R.T. RADIANZ

Primary DI
20705032082553
Brand
S.M.A.R.T. RADIANZ
Company
CORDIS CORPORATION
Model
SR09030L
Catalog number
SR09030L
Device description
S.M.A.R.T. RADIANZ Vascular Stent System 9x30mm 150CM
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032082553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503208255320705032082553

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
806136177
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
10705032019057VISTA BRITE TIP598941P598941P2024-02-23
10705032019170VISTA BRITE TIP598949P598949P2024-02-23
10705032020138VISTA BRITE TIP67004800670048002024-02-23
10705032042956VISTA BRITE TIPSM7497SM74972024-02-23
10705032043069VISTA BRITE TIPSM7540SM75402024-02-23
10705032043144VISTA BRITE TIPSM7548SM75482024-02-23
10705032043151VISTA BRITE TIPSM7549SM75492024-02-23
10705032043434VISTA BRITE TIPSM7596SM75962024-02-23
10705032043779VISTA BRITE TIPSM7652SM76522024-02-23
10705032047050VISTA BRITE TIPSRA0002IGSRA0002IG2024-02-23
10705032047135VISTA BRITE TIPSRA0016IGSRA0016IG2024-02-23
10705032056625ATW Marker Wire Steerable Guidewires595MEJ014595MEJ0142021-01-26
20705032064863VISTA BRITE TIPSM7732SM77322024-02-23
20705032064870VISTA BRITE TIPSM7733SM77332024-02-23
20705032064887VISTA BRITE TIPSM7731SM77312024-02-23
20705032065143VISTA BRITE TIPSM7737SM77372024-02-23
10705032017169VISTA BRITE TIP588823E588823E2016-08-01
10705032017268VISTA BRITE TIP588830E588830E2016-08-01
10705032017299VISTA BRITE TIP588831E588831E2016-08-01
10705032017343VISTA BRITE TIP588834E588834E2016-08-01

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
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
20705032082591S.M.A.R.T. RADIANZCordis US Corp.NIO2022-04-15