FDA.reportPublic FDA data

Endoflux™

Primary DI
04052838002400
Brand
Endoflux™
Company
Medi-Globe GmbH
Model
GBS-01-07-004
Device description
Endoflux™ Biliary Stent, straight with bottom hole, Fr. 7, Length 4 cm
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052838026024PackageGS12In Commercial Distribution
04052838002400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052838026024040528380260244052838026024
04052838002400040528380024004052838002400

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric biliary stent, non-bioabsorbableA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.

Contacts#

Phone, Email table
PhoneEmail
+498032973333sales@medi-globe.de

Regulatory Flags#

DUNS number
318130267
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052838015363OptimizerCAP132CAP1322016-09-22
4052838015370OptimizerCAP132CAP1322016-09-22
04052838011112SonoTip II EBUS FlexGUS-22-18-022GUS-22-18-0222017-01-30
04052838011457SonoTip® EBUS Pro FlexGUS-42-18-022GUS-42-18-0222017-01-30
04052838011471SonoTip® EBUS ProGUS-45-18-022GUS-45-18-0222017-01-30
04052838011495SonoTip® EBUS Pro FlexGUS-46-18-022GUS-46-18-0222017-01-30
04052838009393Injectra, Sclero TipGSN-01-19-180GSN-01-19-1802019-05-15
04052838009430Injectra, Sclero TipGSN-02-23-180GSN-02-23-1802019-05-15
04052838009454Injectra, Sclero TipGSN-02-23-230GSN-02-23-2302019-05-15
04052838009478Injectra, ScleroTipGSN-03-19-120GSN-03-19-1202019-05-15
04052838009492Injectra, Sclero TipGSN-03-19-160GSN-03-19-1602019-05-15
04052838009515Injectra, Sclero TipGSN-03-19-180GSN-03-19-1802019-05-15
04052838009539Injectra, Sclero TipGSN-03-19-210GSN-03-19-2102019-05-15
04052838009577Injectra, Sclero TipGSN-04-23-120GSN-04-23-1202019-05-15
04052838009591Injectra, Sclero TipGSN-04-23-160GSN-04-23-1602019-05-15
04052838009614Injectra, Sclero TipGSN-04-23-180GSN-04-23-1802019-05-15
04052838009638Injectra, Sclero TipGSN-04-23-230GSN-04-23-2302019-05-15
04052838009652Injectra, Sclero TipGSN-05-19-180GSN-05-19-1802019-05-15
04052838009676Injectra, Sclero TipGSN-05-19-230GSN-05-19-2302019-05-15
04052838009690Injectra, Sclero TipGSN-06-19-180GSN-06-19-1802019-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15