FDA.reportPublic FDA data

HANAROSTENT LowAxTM Colon/Rectum(NNN)

Primary DI
08806367076144
Brand
HANAROSTENT LowAxTM Colon/Rectum(NNN)
Company
M.I.Tech Co., Ltd.
Model
CNJF-20-060-230
Device description
Un-covered self-expanding nitinol Colon stent
Published
2018-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQRStent, Colonic, Metallic, Expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQRStent, Colonic, Metallic, ExpandableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180180000HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.2018-11-02MQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806367076144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806367076144088063670761448806367076144

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

Contacts#

Phone, Email table
PhoneEmail
+827043047405andrew@mitech.co.kr

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
04052536219681Small VBR (ADD)Ulrich GmbH & Co. KGMQR2026-03-03
04052536219605ADDUlrich GmbH & Co. KGMQR2025-08-25
04052536009510ADDUlrich GmbH & Co. KGMQR2024-10-29
08809909414367Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414374Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414381Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414398Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414404Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414411Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414428Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414435Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08714729902584WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902591WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902607WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08806367080790HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080820HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080851HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080868HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080899HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080929HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080516HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080547HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080578HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080585HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080615HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080646HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080653HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080684HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080714HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080721HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18