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#

crbard.com

Product Codes#

Code, Name table
Code	Name
FGE	CATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K031186	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K031186	000	LUMINEXX ENDOSCOPIC BILIARY STENT	C.R. Bard, Inc.	2003-05-06	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00801741099298	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00801741099298	00801741099298	801741099298	0801741099298

GMDN Terms#

Term, Definition table
Term	Definition
Bare-metal biliary stent	A 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
Type	Value	Unit
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Store in a cool, dry, dark place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
+4972194450	ute.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 DI	Brand	Model	Catalog	Published
00801741103131	Venovo®	VENUM10040	VENUM10040	2019-03-18
00801741103148	Venovo®	VENUM10060	VENUM10060	2019-03-18
00801741103155	Venovo®	VENUM10080	VENUM10080	2019-03-18
00801741103162	Venovo®	VENUM10100	VENUM10100	2019-03-18
00801741103179	Venovo®	VENUM10120	VENUM10120	2019-03-18
00801741103186	Venovo®	VENUM10140	VENUM10140	2019-03-18
00801741103193	Venovo®	VENUM10160	VENUM10160	2019-03-18
00801741103209	Venovo®	VENUL10040	VENUL10040	2019-03-18
00801741103216	Venovo®	VENUL10060	VENUL10060	2019-03-18
00801741103223	Venovo®	VENUL10080	VENUL10080	2019-03-18
00801741103230	Venovo®	VENUL10100	VENUL10100	2019-03-18
00801741103247	Venovo®	VENUL10120	VENUL10120	2019-03-18
00801741103254	Venovo®	VENUL10140	VENUL10140	2019-03-18
00801741103261	Venovo®	VENUL10160	VENUL10160	2019-03-18
00801741103278	Venovo®	VENUM12040	VENUM12040	2019-03-18
00801741103285	Venovo®	VENUM12060	VENUM12060	2019-03-18
00801741103292	Venovo®	VENUM12080	VENUM12080	2019-03-18
00801741103308	Venovo®	VENUM12100	VENUM12100	2019-03-18
00801741103315	Venovo®	VENUM12120	VENUM12120	2019-03-18
00801741103322	Venovo®	VENUM12140	VENUM12140	2019-03-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000809	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000816	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

Flexxus® Endoscopic Biliary Stent

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Device Sizes#

Storage And Handling#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#