FDA.reportPublic FDA data

Flexxus® Endoscopic Biliary Stent

Primary DI
00801741099298
Brand
Flexxus® Endoscopic Biliary Stent
Company
Angiomed GmbH & Co. Medizintechnik KG
Model
LXB10080
Catalog number
LXB10080
Device description
Flexxus® Endoscopic Biliary Stent, 10 mm x 80 mm (190cm deployment system)
Published
2015-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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
K031186000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031186000LUMINEXX ENDOSCOPIC BILIARY STENTC.R. Bard, Inc.2003-05-06FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741099298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741099298008017410992988017410992980801741099298

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
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry, dark place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4972194450ute.dreschner@crbard.com

Regulatory Flags#

DUNS number
320047483
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741103131Venovo®VENUM10040VENUM100402019-03-18
00801741103148Venovo®VENUM10060VENUM100602019-03-18
00801741103155Venovo®VENUM10080VENUM100802019-03-18
00801741103162Venovo®VENUM10100VENUM101002019-03-18
00801741103179Venovo®VENUM10120VENUM101202019-03-18
00801741103186Venovo®VENUM10140VENUM101402019-03-18
00801741103193Venovo®VENUM10160VENUM101602019-03-18
00801741103209Venovo®VENUL10040VENUL100402019-03-18
00801741103216Venovo®VENUL10060VENUL100602019-03-18
00801741103223Venovo®VENUL10080VENUL100802019-03-18
00801741103230Venovo®VENUL10100VENUL101002019-03-18
00801741103247Venovo®VENUL10120VENUL101202019-03-18
00801741103254Venovo®VENUL10140VENUL101402019-03-18
00801741103261Venovo®VENUL10160VENUL101602019-03-18
00801741103278Venovo®VENUM12040VENUM120402019-03-18
00801741103285Venovo®VENUM12060VENUM120602019-03-18
00801741103292Venovo®VENUM12080VENUM120802019-03-18
00801741103308Venovo®VENUM12100VENUM121002019-03-18
00801741103315Venovo®VENUM12120VENUM121202019-03-18
00801741103322Venovo®VENUM12140VENUM121402019-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
04052838002578Endoflux™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