FDA.reportPublic FDA data

HANAROSTENT® Biliary (NNN)

Primary DI
08806367017642
Brand
HANAROSTENT® Biliary (NNN)
Company
M.I.Tech Co., Ltd.
Model
SHS-10-120-180
Device description
Un-covered self-expanding nitinol biliary stent
Published
2017-07-03
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
K111149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111149000HANAROSTENT BILIARY (NNN)M.I.Tech Co., Ltd.2011-12-30FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806367017642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806367017642088063670176428806367017642

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
Length120Millimeter
Lumen/Inner Diameter10Millimeter

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
+827043047450inae116@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
15711055100400M-DrainMermaid Medical A/SFGE2024-10-01
15711055110041M-DrainMermaid Medical A/SFGE2024-07-20
15711055110409M-DrainMermaid Medical A/SFGE2024-07-20
15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
15711055000328M-DrainMermaid Medical A/SFGE2016-09-24
15711055000359M-DrainMermaid Medical A/SFGE2016-09-24
15711055000373M-DrainMermaid Medical A/SFGE2016-09-24
15711055000410M-DrainMermaid Medical A/SFGE2016-09-24
15711055000434M-DrainMermaid Medical A/SFGE2016-09-24
15711055000458M-DrainMermaid Medical A/SFGE2016-09-24
15711055000472M-DrainMermaid Medical A/SFGE2016-09-24
15711055000496M-DrainMermaid Medical A/SFGE2016-09-24
15711055000519M-DrainMermaid Medical A/SFGE2016-09-24
15711055000533M-DrainMermaid Medical A/SFGE2016-09-24
15711055000557M-DrainMermaid Medical A/SFGE2016-09-24
15711055000588M-DrainMermaid Medical A/SFGE2016-09-24
15711055000595M-DrainMermaid Medical A/SFGE2016-09-24
15711055000625M-DrainMermaid Medical A/SFGE2016-09-24
15711055000632M-DrainMermaid Medical A/SFGE2016-09-24
15711055000663M-DrainMermaid Medical A/SFGE2016-09-24
15711055000670M-DrainMermaid Medical A/SFGE2016-09-24
15711055000700M-DrainMermaid Medical A/SFGE2016-09-24
15711055000724M-DrainMermaid Medical A/SFGE2016-09-24
15711055000748M-DrainMermaid Medical A/SFGE2016-09-24
15711055000762M-DrainMermaid Medical A/SFGE2016-09-24
15711055000779M-DrainMermaid Medical A/SFGE2016-09-24
15711055000809M-DrainMermaid Medical A/SFGE2016-09-24
15711055000816M-DrainMermaid Medical A/SFGE2016-09-24