FDA.report

WALLSTENT® Endoprosthesis

Primary DI
08714729203995
Brand
WALLSTENT® Endoprosthesis
Company
BOSTON SCIENTIFIC CORPORATION
Model
H965403110
Catalog number
H965403110
Device description
Self-Expanding Stent
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MAFSTENT, CORONARY

Product Code Classifications

CodeDeviceSpecialtyClass
MAFStent, CoronaryUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729203995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729203995087147292039958714729203995

GMDN Terms

TermDefinition
Multiple peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
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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