FDA.reportPublic FDA data

COMPLETE SE BILIARY

Primary DI
00613994541956
Brand
COMPLETE SE BILIARY
Company
MEDTRONIC, INC.
Model
SC540L
Device description
STENT SC540L COMPLETE SE LONG US 3L G
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
K062264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062264000COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEMMedtronic Vascular2007-11-08FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994541956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994541956006139945419566139945419560613994541956

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
Length40Millimeter

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
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
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