FDA.reportPublic FDA data

Universa

Primary DI
00827002234468
Brand
Universa
Company
COOK INCORPORATED
Model
G23446
Catalog number
UFH-726-T1
Device description
Universa Firm Ureteral Stent Set With Hydrophilic Coating and Monofilament Tether
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
00827002234468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002234468008270022344688270022344680827002234468

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

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