Q UROLOGICAL PERSISTENT AGUAMEDICINA

Primary DI
00811503033316
Brand
Q UROLOGICAL PERSISTENT AGUAMEDICINA
Company
Q UROLOGICAL CORPORATION
Model
NP377SP0726
Device description
Ureteral Stent
Published
2019-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDAEnteroscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172289000pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation2017-10-04FAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811503033316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811503033316008115030333168115030333160811503033316

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
Storage Environment Temperature35 Degrees Fahrenheit110 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
067206952
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
10811503033511Q UROLOGICAL FUSELAGE AGUAMEDICINA NP377SS0726NP377SS07262020-11-03
10811503033528Q UROLOGICAL FUSELAGE AGUAMEDICINA NP377SS0724NP377SS07242020-11-03
00811503033514Q UROLOGICAL FUSELAGE AGUAMEDICINA NP377SS0726NP377SS07262020-11-03
00811503033521Q UROLOGICAL FUSELAGE AGUAMEDICINA NP377SS0724NP377SS07242020-11-03
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
00811503030506Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331SJ07242019-03-27
00811503030513Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331SJ07242019-03-27
00811503030520Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331SJ07262019-03-27
00811503030537Q UROLOGICAL PERSISTENT AGUAMEDICINA NP331SJ07262019-03-27
00811503031428Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SJ07242019-03-27
00811503031435Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SJ07242019-03-27
00811503031442Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SJ07262019-03-27
00811503031459Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SJ07262019-03-27
00811503031664Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SL07242019-03-27
00811503031671Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SL07242019-03-27
00811503031688Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SL07262019-03-27
00811503031695Q UROLOGICAL PERSISTENT AGUAMEDICINA NP377SL07262019-03-27

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