FDA.reportPublic FDA data

Single-Use Digital Flexible Ureteroscope

Primary DI
06936345110026
Brand
Single-Use Digital Flexible Ureteroscope
Company
Dongguan ZSR Biomedical Technology Company Limited
Model
ZSR-URS-04
Device description
Single-Use Digital Flexible Ureteroscope
Published
2026-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
16936345121784PackageGS11In Commercial Distribution
06936345110026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693634512178416936345121784
06936345110026069363451100266936345110026

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureteroscope, single-useAn endoscope with a flexible 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 typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. 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 single-use device.

Regulatory Flags#

DUNS number
552720970
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936345105749Single-Use Digital Flexible UreteroscopeZSR-URS-012026-10-10
06936345105756Single-Use Digital Flexible UreteroscopeZSR-URS-022026-10-10
06936345110002Single-Use Digital Flexible UreteroscopeZSR-URS-032026-10-10
06936345101536Disposable Ureteral Guide SheathZSR-UA-11352026-05-27
06936345101543Disposable Ureteral Guide SheathZSR-UA-11452026-05-27
06936345104469Disposable Ureteral Guide SheathZSR-UA-10352026-05-27
06936345104476Disposable Ureteral Guide SheathZSR-UA-10452026-05-27
06936345104483Disposable Ureteral Guide SheathZSR-UA-12352026-05-27
06936345104490Disposable Ureteral Guide SheathZSR-UA-12452026-05-27
06936345104544Disposable Ureteral Guide SheathZSR-UA-1235A2026-05-27
06936345104551Disposable Ureteral Guide SheathZSR-UA-1245A2026-05-27
06936345104568Disposable Ureteral Guide SheathZSR-UA-1435A2026-05-27
06936345104575Disposable Ureteral Guide SheathZSR-UA-1445A2026-05-27

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
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
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28