FDA.reportPublic FDA data

Cordis S.M.A.R.T. Control Vascular Stent System

Primary DI
20705032023792
Brand
Cordis S.M.A.R.T. Control Vascular Stent System
Company
Cordis US Corp.
Model
C07040ML
Catalog number
C07040ML
Published
2014-09-19
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
P020036029
P120002004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020036029S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEMCordis US Corporation2003-08-12NIO
P120002004SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMSCordis US Corporation2012-11-07NIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032023792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503202379220705032023792

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
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
10705032100557VISTA BRITE TIP588-842PM588-842PM2024-09-09
10705032100571VISTA BRITE TIP670-052-00M670-052-00M2024-09-09
10705032100595VISTA BRITE TIP670-002-00M670-002-00M2024-09-09
10705032100618VISTA BRITE TIP778-054-00M778-054-00M2024-09-09
10705032100625VISTA BRITE TIP670-034-00M670-034-00M2024-09-09
10705032100649VISTA BRITE TIP670-083-00M670-083-00M2024-09-09
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100670VISTA BRITE TIP670-036-00M670-036-00M2024-09-09
10705032100694VISTA BRITE TIP556-082-0LM556-082-0LM2024-09-09
10705032100700VISTA BRITE TIP670-110-00M670-110-00M2024-09-09
10705032100731VISTA BRITE TIP670-112-00M670-112-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100755VISTA BRITE TIP778-055-00M778-055-00M2024-09-09
10705032100762VISTA BRITE TIP670-055-00M670-055-00M2024-09-09
10705032100779VISTA BRITE TIP556-002-0LM556-002-0LM2024-09-09
10705032100793VISTA BRITE TIP556-080-0LM556-080-0LM2024-09-09
10705032100809VISTA BRITE TIP670-005-00M670-005-00M2024-09-09
10705032100816VISTA BRITE TIP556-054-0LM556-054-0LM2024-09-09
10705032100823VISTA BRITE TIP778-037-00M778-037-00M2024-09-09

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