FDA.reportPublic FDA data

HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)

Primary DI
08806367081148
Brand
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)
Company
M.I.Tech Co., Ltd.
Model
DNJF-20-060-230
Device description
Un-covered self-expanding nitinol duodenum stent
Published
2019-02-18
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
MUMStent, Metallic, Expandable, Duodenal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUMStent, Metallic, Expandable, DuodenalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183616000HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.2019-01-10MQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806367081148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806367081148088063670811488806367081148

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal duodenal stentA sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded 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
Length2300Millimeter
Stent Diameter20Millimeter
Stent Length60Millimeter

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
+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
08809909414329Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414336Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414343Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414350Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08714729902492WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902508WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902515WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08806367081070HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081100HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081131HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081179HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081209HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081216HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081247HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081278HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081285HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081315HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081346HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367076496HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076526HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076557HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076564HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076595HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076625HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076632HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076663HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076694HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076700HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076731HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076762HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20