FDA.reportPublic FDA data

SMART FLEX

Primary DI
20705032065600
Brand
SMART FLEX
Company
Cordis US Corp.
Model
SF05100MB
Catalog number
SF05100MB
Device description
SMART FLEX 5x100 BIL, 120cm
Published
2024-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGEStents, drains and dilators for the biliary ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121125000FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFlexible Stenting Solutions, Inc.2012-07-06FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032065600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503206560020705032065600

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. 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
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
00884450456286ReSolve®Merit Medical Systems, Inc.FGE2026-10-27
00850078427250ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427267ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427274ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427281ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427298ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427304ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427366ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427380ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427427ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427434ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427441ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427458ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427465ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427472ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427489ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27