FDA.reportPublic FDA data

Disposable Ureteral Guide Sheath

Primary DI
06936345104476
Brand
Disposable Ureteral Guide Sheath
Company
Dongguan ZSR Biomedical Technology Company Limited
Model
ZSR-UA-1045
Device description
Disposable Ureteral Guide Sheath
Published
2026-05-27
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241181000Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited2024-08-02FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936345122927PackageGS11In Commercial Distribution
26936345111362PackageGS110In Commercial Distribution
06936345104476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693634512292716936345122927
2693634511136226936345111362
06936345104476069363451044766936345104476

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral introduction sheathA flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. 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
06936345101536Disposable Ureteral Guide SheathZSR-UA-11352026-05-27
06936345101543Disposable Ureteral Guide SheathZSR-UA-11452026-05-27
06936345104469Disposable Ureteral Guide SheathZSR-UA-10352026-05-27
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
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
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