FDA.reportPublic FDA data

X-SUIT NIR BILIARY METALLIC STENT

Primary DI
04953170270673
Brand
X-SUIT NIR BILIARY METALLIC STENT
Company
MEDINOL LTD.
Model
SME-200P-10100
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170270673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170270673049531702706734953170270673

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Outer Diameter10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a clean and dry environment. Do not store in direct sunlight.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600593800
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107017930EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R08US2023-12-17
07290107017947EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R12US2023-12-17
07290107017954EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R15US2023-12-17
07290107017961EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R17US2023-12-17
07290107017978EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R20US2023-12-17
07290107017985EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R24US2023-12-17
07290107017992EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R28US2023-12-17
07290107018005EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM225R33US 2023-12-17
07290107015202EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R08US2023-12-10
07290107015219EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R12US2023-12-10
07290107015226EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R15US2023-12-10
07290107015233EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R17US2023-12-10
07290107015240EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R20US2023-12-10
07290107015257EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R24US2023-12-10
07290107015264EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R28US2023-12-10
07290107015271EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM250R33US2023-12-10
07290107015288EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM275R08US2023-12-10
07290107015295EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM275R12US2023-12-10
07290107015301EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM275R15US 2023-12-10
07290107015318EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemELM275R17US2023-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16932503514658Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515617Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515624Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515631Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515648Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515655Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515662Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515679Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515686Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515693Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515709Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515716Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515723Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515730Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515747Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515754Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515761Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515778Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515785Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515792Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515808Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503513873Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513880Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513897Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513903Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514627Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514634Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514641Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515310Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515327Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01