FDA.report

LifeStar® Biliary Stent

Primary DI
04049519004884
Brand
LifeStar® Biliary Stent
Company
Bard Peripheral Vascular, Inc.
Model
VIUL07120
Catalog number
VIUL07120
Device description
LifeStar® Biliary Stent 7 mm x 120 mm (135 cm delivery catheter)
Published
2015-07-13
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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049519004884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049519004884040495190048844049519004884

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
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags

DUNS number
135057938
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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