FDA.report

COMPLETE SE BILIARY

Primary DI
00613994541994
Brand
COMPLETE SE BILIARY
Company
MEDTRONIC, INC.
Model
SC560L
Device description
STENT SC560L 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

Related Records

Contact Domains

Product Codes

CodeName
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K062264000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K062264000COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEMMedtronic Vascular2007-11-08FGE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613994541994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994541994006139945419946139945419940613994541994

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Length60Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place

Sterilization Methods

Method

Contacts

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

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00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23

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