FDA.reportPublic FDA data

HANAROSTENT® FAST^TM Biliary (NNN)

Primary DI
08806367073716
Brand
HANAROSTENT® FAST^TM Biliary (NNN)
Company
M.I.Tech Co., Ltd.
Model
SHS-08-090-S180
Device description
Un-covered self-expanding nitinol biliary stent with Short guidewire system
Published
2019-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183396000HANAROSTENT FASTTM Biliary (NNN)M.I.Tech Co., Ltd.2019-02-11FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806367073716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806367073716088063670737168806367073716

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Stent Diameter8Millimeter
Stent Length90Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827043047405andrew@mitech.co.kr
+821042945040skim@mitechglobal.com

Regulatory Flags#

DUNS number
688454359
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806367080516HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-060-1402019-02-18
08806367080547HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-090-1402019-02-18
08806367080578HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-120-1402019-02-18
08806367080585HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-060-2302019-02-18
08806367080615HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-090-2302019-02-18
08806367080646HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-20-120-2302019-02-18
08806367080653HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-060-1402019-02-18
08806367080684HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-090-1402019-02-18
08806367080714HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-120-1402019-02-18
08806367080721HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-060-2302019-02-18
08806367080752HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-090-2302019-02-18
08806367080783HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-22-120-2302019-02-18
08806367080790HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-060-1402019-03-11
08806367080820HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-090-1402019-03-11
08806367080851HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-120-1402019-03-11
08806367080868HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-060-2302019-03-11
08806367080899HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-090-2302019-03-11
08806367080929HANAROSTENT® LowAxTM Colon/Rectum(NNN)CNJF-25-120-2302019-03-11
08806367081070HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)DNJF-20-060-1402019-02-18
08806367081100HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)DNJF-20-090-1402019-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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06959664926048NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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06959664926734NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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06959664927403NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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