SEPLOU
- Primary DI
- 06976358502142
- Brand
- SEPLOU
- Company
- SEPLOU (ZHUHAI) CO.,LTD.
- Model
- URS3016E
- Device description
- The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
- Published
- 2025-09-17
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K250049 | 000 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K250049 | 000 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | Seplou (Zhuhai) Co., Ltd. | 2025-08-26 | FGB |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06976358502142 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06976358502142 | 06976358502142 | 6976358502142 |
GMDN Terms
| Term | Definition |
|---|---|
| Flexible video ureteroscope, single-use | An 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. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 847378548
- 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
- false
- 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 | Catalog | Published |
|---|---|---|---|---|
| 06976358502135 | SEPLOU | URS3016 | 2025-09-17 | |
| 06976358502159 | SEPLOU | URS3006 | 2025-09-17 | |
| 06976358502166 | SEPLOU | URS3006E | 2025-09-17 | |
| 06976358502173 | SEPLOU | URS3005 | 2025-09-17 | |
| 06976358502180 | SEPLOU | URS3005E | 2025-09-17 | |
| 06976358503668 | SEPLOU | SPAS1028 | 2025-09-17 | |
| 06976358503675 | SEPLOU | SPAS1035 | 2025-09-17 | |
| 06976358503682 | SEPLOU | SPAS1045 | 2025-09-17 | |
| 06976358503699 | SEPLOU | SPAS1135 | 2025-09-17 | |
| 06976358503705 | SEPLOU | SPAS1145 | 2025-09-17 | |
| 06976358503712 | SEPLOU | SPAS1235 | 2025-09-17 | |
| 06976358503729 | SEPLOU | SPAS1245 | 2025-09-17 | |
| 06976358503736 | SEPLOU | SPAS1335 | 2025-09-17 | |
| 06976358503743 | SEPLOU | SPAS1345 | 2025-09-17 | |
| 06976358503750 | SEPLOU | SPAS1435 | 2025-09-17 | |
| 06976358503767 | SEPLOU | SPAS1445 | 2025-09-17 | |
| 06976358503774 | SEPLOU | SPAS1033S | 2025-09-17 | |
| 06976358503781 | SEPLOU | SPAS1040S | 2025-09-17 | |
| 06976358503798 | SEPLOU | SPAS1050S | 2025-09-17 | |
| 06976358503804 | SEPLOU | SPAS1140S | 2025-09-17 |
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|---|---|---|---|---|
| 06972520301216 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 06972520301223 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 06972520301230 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 06972520301247 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 06972520301254 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 06972520301261 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 06972520301278 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 06972520301285 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2026-03-17 |
| 00810116023370 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | FGB | 2026-01-22 |
| 00810116023417 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | FGB | 2026-01-22 |
| 00810116023523 | Axis II | DORNIER MEDTECH AMERICA, INC. | FGB | 2026-01-22 |
| 00810116023585 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | FGB | 2026-01-22 |
| 16971176282921 | Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 16971176282938 | Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 06971176282948 | Single Use Flexible Video Ureteroscope | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 16971176282952 | Single Use Flexible Video Ureteroscope | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 16971176282969 | Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 06971176282979 | Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 16971176282983 | Single Use Flexible Video Ureteroscope | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 16971176282990 | Single Use Flexible Video Ureteroscope | Zhuhai Pusen Medical Technology Co, Ltd | FGB | 2026-01-13 |
| 06972520300677 | Endoscopic Video Image Processor | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520301759 | Single-Use Video Flexible Ureterorenoscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520301766 | Single-Use Video Flexible Ureterorenoscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520301773 | Single-Use Video Flexible Ureterorenoscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520301780 | Single-Use Video Flexible Ureterorenoscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520302794 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520302800 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520302817 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520302824 | Ascend™ Single-Use Flexible Ureteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
| 06972520303067 | Endoscopic Video Image Processor HD | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |