FDA.reportPublic FDA data

Percuflex™

Primary DI
08714729031796
Brand
Percuflex™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001235490
Catalog number
M001235490
Device description
Ureteral Stent System with Dissolving Tip
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FADSTENT, URETERAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729031796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729031796087147290317968714729031796

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729390275Maverick™ XLH74937909401502016-09-24
08714729390282Maverick™ XLH74937909402002016-09-24
08714729390299Maverick™ XLH74937909451502016-09-24
08714729390305Maverick™ XLH74937909452002016-09-24
08714729390312Maverick™ XLH74937909501502016-09-24
08714729390329Maverick™ XLH74937909502002016-09-24
08714729390336Maverick™ XLH74937909551502016-09-24
08714729390343Maverick™ XLH74937909552002016-09-24
08714729390350Maverick™ XLH74937909601502016-09-24
08714729390367Maverick™ XLH74937909602002016-09-24
08714729739258NAM0014416602016-09-24
08714729860488WATCHMAN FLX™M635WU50200M635WU502002020-07-28
08714729860495WATCHMAN FLX™M635WU50240M635WU502402020-07-28
08714729860501WATCHMAN FLX™M635WU50270M635WU502702020-07-28
08714729860518WATCHMAN FLX™M635WU50310M635WU503102020-07-28
08714729860525WATCHMAN FLX™M635WU50350M635WU503502020-07-28
08714729848851Vessix™H749RDNDCR145002016-09-24
08714729848868Vessix™H749RDNDCL145002016-09-24
00802526628900LATITUDE™ Programming System330033002026-05-14
08714729224419Maverick®H74920620153702016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729005254Percuflex™ Combination Stent/Nephrostomy CatheterBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031680Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031697Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031703Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031802Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031819Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031826Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031833Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031840Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729031857Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032090Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032106Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032113Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032120Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729032137Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048381Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048398Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048404Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048411Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048428Percuflex™ Nephroureteral StentBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048459Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048466Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048473Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048602Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048633Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048640Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048657Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048664Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048671Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729048688Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24