S.M.A.R.T.

Primary DI: 20705032024935
Brand: S.M.A.R.T.
Company: CORDIS CORPORATION
Model: C14030SB
Catalog number: C14030SB
Device description: SMART 7FR 80CM BILIARY 14X30
Published: 2017-09-26
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
K031777	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K031777	000	MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corp.	2003-07-07	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
20705032024935	Primary	GS1	0
10705032024938	Unit of Use	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifier	GTIN-14 normalized
20705032024935	20705032024935
10705032024938	10705032024938

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.

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	15 Degrees Celsius	30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 806136177
Device count: 1
Lot or batch: true
Expiration date on label: true
No natural rubber latex: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
10705032000512	AVANTI+	402604T	402604T	2016-08-01
10705032000550	AVANTI	402605R	402605R	2016-08-01
10705032000772	AVANTI+	402611T	402611T	2016-08-01
10705032009751	AVANTI	504404X	504404X	2016-08-01
10705032009782	AVANTI	504407X	504407X	2016-08-01
10705032009805	AVANTI	504409X	504409X	2016-08-01
10705032009812	AVANTI	504504S	504504S	2016-08-01
10705032009829	AVANTI	504505S	504505S	2016-08-01
10705032009836	AVANTI	504505X	504505X	2016-08-01
10705032009843	AVANTI	504506S	504506S	2016-08-01
10705032009850	AVANTI	504506X	504506X	2016-08-01
10705032009867	AVANTI	504507X	504507X	2016-08-01
10705032009874	AVANTI	504508X	504508X	2016-08-01
10705032009928	AVANTI	504604T	504604T	2016-08-01
10705032009973	AVANTI	504605T	504605T	2016-08-01
10705032010009	AVANTI	504606D	504606D	2016-08-01
10705032010016	AVANTI	504606P	504606P	2016-08-01
10705032010023	AVANTI	504606S	504606S	2016-08-01
10705032010030	AVANTI	504606T	504606T	2016-08-01
10705032010054	AVANTI	504606X	504606X	2016-08-01

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

S.M.A.R.T.

Related Records#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Storage And Handling#

Sterilization Methods#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#