FDA.reportPublic FDA data

RACER® BILIARY

Primary DI
00613994551436
Brand
RACER® BILIARY
Company
MEDTRONIC, INC.
Model
XD718YL
Device description
STENT XD718YL RACER US LONG
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#

Product Codes#

Code, Name table
CodeName
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032768000MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)Medtronic Ave, Inc.2003-10-09FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994551436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994551436006139945514366139945514360613994551436

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA 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
TypeValueUnit
Device Size Text, specify0
Length18Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.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 DIBrandModelCatalogPublished
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055100400M-DrainMermaid Medical A/SFGE2024-10-01
15711055110041M-DrainMermaid Medical A/SFGE2024-07-20
15711055110409M-DrainMermaid Medical A/SFGE2024-07-20
15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
15711055000328M-DrainMermaid Medical A/SFGE2016-09-24
15711055000359M-DrainMermaid Medical A/SFGE2016-09-24
15711055000373M-DrainMermaid Medical A/SFGE2016-09-24
15711055000410M-DrainMermaid Medical A/SFGE2016-09-24
15711055000434M-DrainMermaid Medical A/SFGE2016-09-24
15711055000458M-DrainMermaid Medical A/SFGE2016-09-24
15711055000472M-DrainMermaid Medical A/SFGE2016-09-24
15711055000496M-DrainMermaid Medical A/SFGE2016-09-24
15711055000519M-DrainMermaid Medical A/SFGE2016-09-24
15711055000533M-DrainMermaid Medical A/SFGE2016-09-24
15711055000557M-DrainMermaid Medical A/SFGE2016-09-24
15711055000588M-DrainMermaid Medical A/SFGE2016-09-24
15711055000595M-DrainMermaid Medical A/SFGE2016-09-24
15711055000625M-DrainMermaid Medical A/SFGE2016-09-24
15711055000632M-DrainMermaid Medical A/SFGE2016-09-24
15711055000663M-DrainMermaid Medical A/SFGE2016-09-24
15711055000670M-DrainMermaid Medical A/SFGE2016-09-24
15711055000700M-DrainMermaid Medical A/SFGE2016-09-24
15711055000724M-DrainMermaid Medical A/SFGE2016-09-24
15711055000748M-DrainMermaid Medical A/SFGE2016-09-24
15711055000762M-DrainMermaid Medical A/SFGE2016-09-24
15711055000779M-DrainMermaid Medical A/SFGE2016-09-24
15711055000809M-DrainMermaid Medical A/SFGE2016-09-24
15711055000816M-DrainMermaid Medical A/SFGE2016-09-24