FDA.reportPublic FDA data

NA

Primary DI
07613327063592
Brand
NA
Company
STRYKER CORPORATION
Model
0502880430
Catalog number
0502-880-430
Device description
6.9/10 Fr. SRU-6X, Semi-Rigid Ureteroscope, Autoclavable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGBUreteroscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327063592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327063592076133270635927613327063592

GMDN Terms#

Term, Definition table
TermDefinition
Rigid ureteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length43Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327060027Precision Ideal Eyes05028190300502-819-0302016-09-23
07613327060072Precision Ideal Eyes05028230300502-823-0302016-09-23
07613327060102Precision Ideal Eyes05028231300502-823-1302016-09-23
07613327060119Precision Ideal Eyes05028270100502-827-0102016-09-23
07613327060126Precision Ideal Eyes05028230700502-823-0702016-09-23
07613327060140Precision Ideal Eyes05028270700502-827-0702016-09-23
07613327060157Precision Ideal Eyes05028271300502-827-1302016-09-23
07613327060164Precision Ideal Eyes05028270300502-827-0302016-09-23
07613327060232Precision Ideal Eyes05028230100502-823-0102016-09-23
07613327063875Precision Ideal Eyes, Speed-Lock05029270100502-927-0102016-09-23
07613327063882Precision Ideal Eyes, Speed-Lock05029270300502-927-0302016-09-23
07613327063899Precision Ideal Eyes, Speed-Lock05029270700502-927-0702016-09-23
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936345105749Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
06936345105756Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
06936345110002Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
06936345110026Single-Use Digital Flexible UreteroscopeDongguan ZSR Biomedical Technology Company LimitedFGB2026-10-10
06972520302534Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302541Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302558Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302565Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302831Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302848Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302855Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06972520302862Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-09-22
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28