FDA.reportPublic FDA data

Porges Coloplast

Primary DI
03600040302279
Brand
Porges Coloplast
Company
Coloplast A/S
Model
AJ5065
Catalog number
AJ5065
Device description
SILICONE Double loop ureteral stent open/open CH FR 06 length 28 cm with connectable pusher CH FR 06 and Orchestra™ guidewire
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

Contact Domains#

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
03600040302279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03600040302279036000403022793600040302279

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
Catheter Gauge6French
Length28Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from light in a cool and dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30
05701780444026SenSura Mio Convex1683201683202026-04-30

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