FDA.report

LifeStent® XL Vascular & Biliary Stent System

Primary DI
04049519007908
Brand
LifeStent® XL Vascular & Biliary Stent System
Company
Bard Peripheral Vascular, Inc.
Model
EX051201CS
Catalog number
EX051201CS
Device description
BARD® LIFESTENT® XL Vascular and Biliary Stent System 5 mm x 120 mm (80 cm delivery catheter)
Published
2014-09-17
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
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications

CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049519007908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049519007908040495190079084049519007908

GMDN Terms

TermDefinition
Iliac artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Disposable devices associated with 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
Special Storage Condition, Specify00Store in a cool, dry, dark place.
Storage Environment Temperature060 Degrees Celsius

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
false
Sterilization required before use
false

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