FDA.report

Epic™ Biliary

Primary DI
08714729896883
Brand
Epic™ Biliary
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00572260
Device description
Stent System
Published
2017-08-31
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
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729896883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729896883087147298968838714729896883

GMDN Terms

TermDefinition
Bare-metal biliary stentA non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. 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

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
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 DIBrandModelCatalogPublished
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24
08714729181163Percuflex™ BiliaryM005338502015-09-24
08714729181217Percuflex™ BiliaryM005336102015-09-24
08714729181224Percuflex™ BiliaryM005336202015-09-24
08714729181231Percuflex™ BiliaryM005336302015-09-24
08714729181248Percuflex™ BiliaryM005336402015-09-24
08714729181255Percuflex™ BiliaryM005336502015-09-24

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