FDA.report

Q UROLOGICAL PERSISTENT AGUAMEDICINA

Primary DI
00811503033262
Brand
Q UROLOGICAL PERSISTENT AGUAMEDICINA
Company
Q UROLOGICAL CORPORATION
Model
NP331SH0724
Device description
Ureteral Stent
Published
2019-03-27
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
FADStent, Ureteral

Product Code Classifications

CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K172289000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K172289000pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation2017-10-04FAD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811503033262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811503033262008115030332628115030332620811503033262

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature35 Degrees Fahrenheit110 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
067206952
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
true
Expiration date on label
true
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
00811503033477Q UROLOGICAL FUSELAGE AGUAMEDICINA NP378SS0726NP376SJ07262020-07-16
00811503033484Q UROLOGICAL FUSELAGE AGUAMEDICINA NP378SS07242020-07-16
10811503033474Q UROLOGICAL FUSELAGE AGUAMEDICINA NP378SS07262020-07-16
10811503033481Q UROLOGICAL FUSELAGE AGUAMEDICINA NP378SS07242020-07-16
10811503033245Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SH07242019-03-27
10811503033252Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SH07262019-03-27
10811503033269Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331SH07242019-03-27
10811503033276Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331SH07262019-03-27
10811503033306Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331SP07242019-03-27
10811503033313Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SP07262019-03-27
10811503033320Q UROLOGICAL PERSISTENT AGUAMEDICINA NP376SJ07262019-03-27
10811503033337Q UROLOGICAL PERSISTENT AGUAMEDICINA NP376SJ07282019-03-27
10811503033368Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331TP07262019-03-27
10811503033375Q UROLOGICAL PERSISTENT AGUAMEDICINA NP330SP06262019-03-27
10811503033382Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331TP07242019-03-27
10811503033399Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SL75262019-03-27
10811503033405Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377EO08262019-03-27
10811503033412Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377ER08302019-03-27
10811503033429Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377EO08282019-03-27
10811503033436Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SP07282019-03-27

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