FDA.reportPublic FDA data

Flexxus® Endoscopic Biliary Stent

Primary DI
00801741099304
Brand
Flexxus® Endoscopic Biliary Stent
Company
Angiomed GmbH & Co. Medizintechnik KG
Model
LXB10100
Catalog number
LXB10100
Device description
Flexxus® Endoscopic Biliary Stent, 10 mm x 100 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
00801741099304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741099304008017410993048017410993040801741099304

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06959664925584NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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06959664926017NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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06959664926314NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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06959664929001NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
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