FDA.reportPublic FDA data

Polaris™ Ultra

Primary DI
08714729880837
Brand
Polaris™ Ultra
Company
BOSTON SCIENTIFIC CORPORATION
Model
M006192115030
Device description
Ureteral Stent Set
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
08714729880837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729880837087147298808378714729880837

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric ureteral stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

Device Sizes#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729270133Polaris X™M0047000D0M0047000D02016-09-24
08714729270140Polaris X™M0047001D0M0047001D02016-09-24
08714729270164Polaris X™M0047003D0M0047003D02016-09-24
08714729270171Polaris X™M0047004D0M0047004D02016-09-24
08714729270188Polaris X™M0047005D0M0047005D02016-09-24
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24

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
08714729031796Percuflex™BOSTON 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