IntraStent LD Mega

Primary DI: 00821684014059
Brand: IntraStent LD Mega
Company: Covidien LP
Model: S17-16
Device description: Large Diameter Biliary Stent
Published: 2015-10-09
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
00821684014059	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
00821684014059	00821684014059	821684014059	0821684014059

GMDN Terms#

Term, Definition table
Term	Definition
Multiple peripheral artery stent, bare-metal	A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Device Size Text, specify	0
Length	16	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#