FDA.reportPublic FDA data

SEPLOU

Primary DI
06976358503774
Brand
SEPLOU
Company
SEPLOU (ZHUHAI) CO.,LTD.
Model
SPAS1033S
Device description
The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976358503774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976358503774069763585037746976358503774

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
847378548
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976358502845SEPLOUSPRB11132026-05-14
06976358502852SEPLOUSPRB11152026-05-14
06976358502869SEPLOUSPRB11172026-05-14
06976358502876SEPLOUSPRB11182026-05-14
06976358502883SEPLOUSPRB11192026-05-14
06976358502890SEPLOUSPRB11222026-05-14
06976358502906SEPLOUSPRB22302026-05-14
06976358502913SEPLOUSPRB13152026-05-14
06976358502920SEPLOUSPRB13172026-05-14
06976358502937SEPLOUSPRB13182026-05-14
06976358502944SEPLOUSPRB13192026-05-14
06976358502951SEPLOUSPRB1113Z2026-05-14
06976358502968SEPLOUSPRB1115Z2026-05-14
06976358502975SEPLOUSPRB1117Z2026-05-14
06976358502982SEPLOUSPRB1118Z2026-05-14
06976358502999SEPLOUSPRB1119Z2026-05-14
06976358503002SEPLOUSPRB1122Z2026-05-14
06976358503019SEPLOUSPRB2230Z2026-05-14
06976358503026SEPLOUSPRB1315Z2026-05-14
06976358503033SEPLOUSPRB1317Z2026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551738TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551745TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551752TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551769TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551776TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551783TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
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
06936345104476Disposable 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
06925816667213ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06970462547457Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547464Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547471Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547488Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547495Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547501Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547518Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547525Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547532Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547549Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547556Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10