FDA.reportPublic FDA data

HANAROSTENT® Benefit™ Biliary (NNN)

Primary DI
08806367092977
Brand
HANAROSTENT® Benefit™ Biliary (NNN)
Company
M.I.Tech Co., Ltd.
Model
BNHS-08-070-060
Device description
Un-covered self-expanding nitinol biliary stent
Published
2021-08-31
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
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202973000HANAROSTENT Benefit Biliary (NNN)M.I.Tech Co., Ltd.2021-05-11FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806367092977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806367092977088063670929778806367092977

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
Device Size Text, specify0
Stent Diameter8Millimeter
Stent Length70Millimeter

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
+827043047474jae@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
00850078427250ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427267ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427274ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427281ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427298ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427304ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427366ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427380ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427427ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427434ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427441ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427458ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427465ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427472ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427489ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27