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
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994963826NIH™0087612016-07-24
00613994964274NIH™ Cardio-Marker0100112016-06-10
00613994964540Lehman™0012592016-06-05
00613994964564Lehman™0012632016-06-05
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00681490860659DLPCB140172016-05-22
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16932503514658Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515617Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515624Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515631Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515648Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515655Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515662Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515679Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515686Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515693Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515709Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515716Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515723Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515730Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515747Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515754Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515761Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515778Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515785Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515792Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515808Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503513873Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513880Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513897Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513903Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514627Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514634Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514641Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515310Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515327Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01