FDA.reportPublic FDA data

NA

Primary DI
07613327063493
Brand
NA
Company
STRYKER CORPORATION
Model
0502880330
Catalog number
0502-880-330
Device description
6.9/10 Fr. SRU-6, 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
07613327063493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327063493076133270634937613327063493

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
Length33Centimeter

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
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
06972520301216Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
00810116023370Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023417Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023523Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023585Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
06971176282924Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13