RACER® BILIARY

Primary DI: 00613994551481
Brand: RACER® BILIARY
Company: MEDTRONIC, INC.
Model: XD618YF
Device description: STENT XD618YF RACER US SHORT
Published: 2015-06-08
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: MR Conditional
Rx: true
Sterile: true
Single use: true

Contact Domains#

medtronic.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
K032768	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K032768	000	MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)	Medtronic Ave, Inc.	2003-10-09	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00613994551481	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
00613994551481	00613994551481	613994551481	0613994551481

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	18	Millimeter

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Store at room temperature in a dark, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
+1(800)633-8766	Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number: 006261481
Device count: 1
Lot or batch: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Published
00199150083855	NA	BB10L80R8	2026-06-08
00199150083992	NA	BB8B99R9	2026-06-08
00199150084180	NA	1D92R4	2026-06-08
00824846000020	NA	BB12W54R2	2026-06-08
00824846000983	NA	BB12W65R	2026-06-08
00824846001027	NA	BB12C06R5	2026-06-08
00824846001041	NA	BB12W64R	2026-06-08
00824846001065	NA	BB12V57R	2026-06-08
00643169530102	ATTAIN CLARITY™	6225	2016-07-16
00613994746610	ATTAIN SELECT™ II	6248130D02	2016-07-16
00613994746801	ATTAIN SELECT™ II	6248DEL90DS02	2016-04-11
20763000946979	DLP®	87220	2024-08-15
00199150078455	NA	11N40R1	2026-04-26
20643169454594	DLP®	30317	2016-09-09
00199150083077	NA	12V42R	2026-05-30
00199150083121	NA	BB1119R7	2026-05-30
00199150083381	NA	BB12M28R12	2026-05-30
00199150083442	NA	BB5G97R13	2026-05-30
00199150083534	NA	BB10U10R17	2026-05-30
00199150083718	NA	BB6Z03R10	2026-05-30

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

RACER® BILIARY

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#