BONASTENT® Biliary

Primary DI: 08806369461443
Brand: BONASTENT® Biliary
Company: Sewoon Medical Co., Ltd.
Model: BB-100618
Published: 2017-03-03
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: MR Conditional
Rx: true
Sterile: true
Single use: true

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
K140760	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K140760	000	BONASTENT BILIARY	Endochoice, Inc.	2014-06-16	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
08806369461443	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
08806369461443	08806369461443	8806369461443

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 687784405
Device count: 1
Lot or batch: true
Serial number: 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	Published
08806369400220	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200M2+(3.2)	2023-07-27
08806369400244	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L2+(4.8)	2023-07-27
08806369427333	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100M(3.2)S	2023-07-27
08806369427371	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200M(3.2)S	2023-07-27
08806369427418	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L(4.8)S	2023-07-27
08806369427456	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS200L+(4.8)S	2023-07-27
08806369427494	BAROVAC® Evacuator Closed Wound Drainage System(SS)	PS400L(4.8)S	2023-07-27
08806369427616	BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400M(3.2)N273	2023-07-27
08806369427654	BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400L(4.8)N273	2023-07-27
08806369427692	BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400S(2.4)	2023-07-27
08806369427739	BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400M(3.2)S	2023-07-27
08806369427777	BAROVAC® Evacuator Closed Wound Drainage System(PP)	PP400L(4.8)S	2023-07-27
08806369452007	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100M(3.2)	2023-07-27
08806369452021	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100M+(3.2)	2023-07-27
08806369452045	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100L(4.8)	2023-07-27
08806369452069	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100L+(4.8)	2023-07-27
08806369452083	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100LD(4.8)	2023-07-27
08806369452106	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100JP(4.8)	2023-07-27
08806369452120	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS100M2(3.2)	2023-07-27
08806369452526	BAROVAC® Evacuator Closed Wound Drainage System(SS)	SS150M+(3.2)	2023-07-27

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

BONASTENT® Biliary

Related Records#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Device Sizes#

Sterilization Methods#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#