Soehendra

Primary DI: 00827002215733
Brand: Soehendra
Company: COOK INCORPORATED
Model: G21573
Catalog number: SBDC-7
Device description: Soehendra Biliary Dilation Catheter
Published: 2018-06-19
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#

cookmedical.com

Product Codes#

Code, Name table
Code	Name
FGE	Stents, drains and dilators for the biliary ducts

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
K171548	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K171548	000	Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter	Wilson-Cook Medical, Inc.	2017-10-13	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00827002215733	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
00827002215733	00827002215733	827002215733	0827002215733

GMDN Terms#

Term, Definition table
Term	Definition
Biliary drainage catheter	A flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device.

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
+1(812)330-5494	sharedservices@cookmedical.com

Regulatory Flags#

DUNS number: 079720472
Device count: 1
Lot or batch: 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	Catalog	Published
00827002000766	Cook	G00076	MDC-6	2020-10-02
00827002000773	Cook	G00077	MDC-7	2020-10-02
00827002000780	Cook	G00078	MDC-8	2020-10-02
00827002009653	Cook	G00965	MDC-10	2020-10-02
00827002009660	Cook	G00966	MDC-5	2020-10-02
00827002010796	Cook	G01079	MDC-9	2020-10-02
00827002013209	Cook	G01320	MDC-12	2020-10-02
00827002014626	Cook	G01462	MDC-14	2020-10-02
00827002016170	Cook	G01617	MDC-16	2020-10-02
00827002026896	Cook	G02689	MDC-4	2020-10-02
00827002027350	Cook	G02735	MDC-3	2020-10-02
00827002048881	Cook	G04888	FD-100	2020-10-02
00827002541900	Guardia	G54190	J-UOB-4028	2016-09-24
00827002541917	Guardia	G54191	J-UOB-4028-ST	2016-09-24
00827002614994	MagniCore	G61499	MRCHN-20-15.0	2026-03-27
00827002615007	MagniCore	G61500	MRCHN-18-10.0	2026-03-27
00827002615014	MagniCore	G61501	MRCHN-18-15.0	2026-03-27
00827002615021	MagniCore	G61502	MRCHN-18-20.0	2026-03-27
00827002615038	MagniCore	G61503	MRCHN-20-10.0	2026-03-27
00827002615045	MagniCore	G61504	MRCHN-20-20.0	2026-03-27

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

Soehendra

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Storage And Handling#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#