IntraStent LD Mega

Primary DI: 00821684014073
Brand: IntraStent LD Mega
Company: Covidien LP
Model: S17-36
Device description: Large Diameter Biliary Stent
Published: 2015-10-12
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Sterile: true
Single use: true

Contact Domains#

covidien.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
K020528	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K020528	000	INTRASTENT LD (LARGE DIAMETER) STENT	Sulzer Intratherapeutics, Inc.	2002-04-16	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00821684014073	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
00821684014073	00821684014073	821684014073	0821684014073

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
Length	36	Millimeter

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
+1(508)261-8000	covidien.udi@covidien.com

Regulatory Flags#

DUNS number: 968903703
Device count: 1
Lot or batch: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Published
10884521845985	INVOS	PMC71VP-GE	2025-07-03
10884521063150	ILA	3948L	2015-08-28
10884521102422	Steel	88862345-53	2015-08-31
10884521103863	TaperGuard	18780S	2016-09-24
10884521211933	Shiley	5-18237	2017-05-10
10884521543799	Signia	SIGPSHELL	2017-08-08
10884521713208	Edge	E1455B	2016-11-18
10884521713277	Edge	E1475X	2016-11-18
20884521103631	Mallinckrodt	5-18237	2015-08-28
20884521105574	Mallinckrodt	5-18541	2015-08-28
40884521105578	Shiley	5-18541	2018-05-16
10884521543881	Signia	SIGMRET	2017-07-24
10884521543874	Signia	SIGRIG	2017-07-31
10884521620254	Shiley	86234	2016-09-24
10884521543812	Signia	SIGADAPTXL	2017-08-08
10884521101098	Nellcor	MAXPACAI	2016-09-24
10884521543782	Signia	SIGPHANDLE	2017-08-08
10884521543867	Signia	SIGSBCHGR	2017-08-01
10884521128927	Sonicision	SCST	2016-09-24
10884521543829	Signia	SIGADAPTSHORT	2017-09-12

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

IntraStent LD Mega

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#