FDA.reportPublic FDA data

S.M.A.R.T.

Primary DI
20705032025017
Brand
S.M.A.R.T.
Company
Cordis US Corp.
Model
C14060SB
Catalog number
C14060SB
Device description
SMART 7FR 80CM BILIARY 14X60
Published
2017-09-19
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
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120002000SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMSCordis US Corporation2012-11-07NIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032025017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503202501720705032025017

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.

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
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
10705032009775AVANTI504406X504406X2016-08-01
10705032009799AVANTI504408X504408X2016-08-01
10705032009881AVANTI504509X504509X2016-08-01
10705032009898AVANTI504604A504604A2016-08-01
10705032009904AVANTI504604P504604P2016-08-01
10705032009911AVANTI504604S504604S2016-08-01
10705032009935AVANTI504604X504604X2016-08-01
10705032009942AVANTI504605A504605A2016-08-01
10705032009959AVANTI504605P504605P2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002037960Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002037977Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002037991Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038004Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038011Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038028Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182370Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182387Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182394Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182417Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182431Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182448Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182455Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182462Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182479Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182493Zilver FlexCOOK IRELAND LTDNIP2025-12-04
20705032082331S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
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
20705032082409S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082423S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082447S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082485S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082508S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082553S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082584S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082614S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082652S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
00733132645725GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16