FDA.reportPublic FDA data

Endoflux™

Primary DI
04052838002578
Brand
Endoflux™
Company
Medi-Globe GmbH
Model
GBS-01-08-005
Device description
Endoflux™ Biliary Stent, straight with bottom hole, Fr. 8.5, Length 5 cm
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
04052838026147PackageGS12In Commercial Distribution
04052838002578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052838026147040528380261474052838026147
04052838002578040528380025784052838002578

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
04052838002417Endoflux™GBS-01-07-0052026-08-27
04052838002424Endoflux™GBS-01-07-005S2026-08-27
04052838002431Endoflux™GBS-01-07-0062026-08-27
04052838002448Endoflux™GBS-01-07-0072026-08-27
04052838002455Endoflux™GBS-01-07-007S2026-08-27
04052838002462Endoflux™GBS-01-07-0092026-08-27
04052838002479Endoflux™GBS-01-07-009S2026-08-27
04052838002486Endoflux™GBS-01-07-0102026-08-27
04052838002493Endoflux™GBS-01-07-0112026-08-27
04052838002509Endoflux™GBS-01-07-0122026-08-27
04052838002516Endoflux™GBS-01-07-012S2026-08-27
04052838002523Endoflux™GBS-01-07-0142026-08-27
04052838002530Endoflux™GBS-01-07-0152026-08-27
04052838002547Endoflux™GBS-01-07-015S2026-08-27
04052838002554Endoflux™GBS-01-07-0162026-08-27
04052838002561Endoflux™GBS-01-08-0042026-08-27
04052838002585Endoflux™GBS-01-08-005S2026-08-27
04052838002592Endoflux™GBS-01-08-0062026-08-27
04052838002608Endoflux™GBS-01-08-0072026-08-27
04052838002615Endoflux™GBS-01-08-007S2026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002448Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002455Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002462Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002479Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002486Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002493Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002509Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002516Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002523Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002530Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002547Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002554Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002561Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002585Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002592Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002608Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002615Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002622Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002639Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002646Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002653Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002660Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002677Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002684Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002691Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002707Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002714Endoflux™Medi-Globe GmbHFGE2026-08-27