IntraStent LD DoubleStrut

Primary DI: 00821684014110
Brand: IntraStent LD DoubleStrut
Company: Covidien LP
Model: S15-16
Device description: Large Diameter Peripheral 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
K993904	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K993904	000	INTRASTENT DOUBLESTRUT LD	Intratherapeutics, Inc.	2000-02-01	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00821684014110	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
00821684014110	00821684014110	821684014110	0821684014110

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
10884521620193	Shiley	18775S	2017-04-18
10884521620209	Shiley	18780S	2017-01-06
10884521543805	Signia	SIGADAPTSTND	2017-08-08
10884521824355	McGRATH	X3-003-000	2021-09-01
10884521032903	Biosyn	GMT-226	2015-09-01
10884521073517	Versaport	NBFCA5ST	2016-09-24
10884521085329	Sofsilk	GSJ-36-M	2015-09-01
10884521085336	Sofsilk	GSJ-37-M	2015-09-01
10884521101999	Vascufil	88864722-21V	2015-08-31
10884521191013	Endo GIA	EGIATRS60AMT	2015-09-01
10884521543522	Tri-Staple 2.0	SIGC60VT	2017-05-26
10884521543638	Tri-Staple 2.0	SIGTRS60AMT	2017-05-26
10884521726352	ReliaTack	RELTACK8RDPTSW	2018-06-03
10884523000627	SILS	SILSHOOK36	2016-09-24
10884523000917	Surgiwand II	178094	2016-09-24
10884523006599	Premium Plus CEEA	111985	2015-08-28
10884524001500	Valleylab	E2516HS	2016-09-24
10884521195202	Sonicision	SCD13	2018-08-10
10884521807884	Sonicision	SCD13	2020-06-29
10884521546219	LigaSure	LIGASUREZD	2018-09-08

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 DoubleStrut

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#