LithoVue™ Elite
- Primary DI
- 08714729997351
- Brand
- LithoVue™ Elite
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M0067941000
- Catalog number
- M0067941000
- Device description
- Single-Use Digital Flexible Ureteroscope
- Published
- 2024-02-16
- 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 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729997351 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729997351 | 08714729997351 | 8714729997351 |
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
- 021717889
- 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
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|---|---|---|---|---|
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| 08714729195566 | RotaWire™ and wireClip™ Torquer | H802228240020 | H802228240020 | 2014-09-24 |
| 08714729837527 | Stingray™ | H749M3004A0 | 2016-09-24 | |
| 08714729877523 | EP XT™ | M0042007720 | M0042007720 | 2016-09-24 |
| 08714729877714 | Dynamic XT™ | M0042011120 | M0042011120 | 2016-09-24 |
| 08714729879947 | EP XT™ | M0046EPXT00390 | M0046EPXT00390 | 2016-09-24 |
| 08714729181088 | Percuflex™ Biliary | M00533760 | 2015-09-24 | |
| 08714729181095 | Percuflex™ Biliary | M00533770 | 2015-09-24 | |
| 08714729181101 | Percuflex™ Biliary | M00533780 | 2015-09-24 | |
| 08714729181118 | Percuflex™ Biliary | M00533790 | 2015-09-24 | |
| 08714729181125 | Percuflex™ Biliary | M00533800 | 2015-09-24 | |
| 08714729181132 | Percuflex™ Biliary | M00533810 | 2015-09-24 | |
| 08714729181149 | Percuflex™ Biliary | M00533820 | 2015-09-24 | |
| 08714729181156 | Percuflex™ Biliary | M00533830 | 2015-09-24 | |
| 08714729181163 | Percuflex™ Biliary | M00533850 | 2015-09-24 | |
| 08714729181217 | Percuflex™ Biliary | M00533610 | 2015-09-24 | |
| 08714729181224 | Percuflex™ Biliary | M00533620 | 2015-09-24 | |
| 08714729181231 | Percuflex™ Biliary | M00533630 | 2015-09-24 | |
| 08714729181248 | Percuflex™ Biliary | M00533640 | 2015-09-24 | |
| 08714729181255 | Percuflex™ Biliary | M00533650 | 2015-09-24 |
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| 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 |
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| 06972520301780 | Single-Use Video Flexible Ureterorenoscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | 2025-12-31 |
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