Uretero1
- Primary DI
- 00724995209162
- Brand
- Uretero1
- Company
- BLACK DIAMOND VIDEO, INC.
- Model
- UROSD101
- Catalog number
- UROSD101
- Device description
- The Uretero1 Standard Deflection Disposable Ureteroscope is a single use flexible ureteroscope that is used to visualize and perform various diagnostic and therapeutic procedures in the urinary tract.
- Published
- 2022-06-10
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
xx.xxProduct 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#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K211347 | 000 | Uretero1 Ureteroscope System | STERIS Corporation | 2021-11-23 | FGB |
| K223466 | 000 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation | 2023-02-17 | FGB |
| K231878 | 000 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation | 2023-07-25 | FGB |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10724995209169 | Package | GS1 | 5 | In Commercial Distribution |
| 00724995209162 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10724995209169 | 10724995209169 | ||
| 00724995209162 | 00724995209162 | 724995209162 | 0724995209162 |
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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 230 | Centimeter |
| Outer Diameter | 2.4 | Millimeter |
| Width | 3 | Centimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Keep Dry |
Contacts#
| Phone | |
|---|---|
| +1(800)548-4873 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 556373053
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00724995245054 | HexaVue | HexaVue Focus | XEHFSLC | 2025-10-17 |
| 00724995245061 | HexaVue | HexaVue Focus | XEHFSLCAMC | 2025-10-17 |
| 00724995220587 | HexaVue | HexaVue IP | XQHPSLC | 2024-02-08 |
| 00724995220594 | HexaVue | HexaVue IP | XQHPILCC | 2024-02-08 |
| 00724995198503 | HexaVue | HexaVue SCC 1.0 | XQHILCC1 | 2021-03-31 |
| 00724995198497 | HexaVue | HexaVue-SLC 1.0 | XQHLC1 | 2020-09-04 |
| 00724995198459 | FREE5 | Free5 Camera | RLQ1080FCS | 2021-04-23 |
| 00724995209179 | Uretero1 | URORD101 | URORD101 | 2022-06-10 |
| 00724995209186 | Vision1 | VIS101 | VIS101 | 2022-06-10 |
| 00724995198473 | NA | IDSS-SCC | XQSILCC1 | 2021-04-23 |
| 00724995199135 | Harmony iQ | Harmony iQ 2800 | RLQ2000SLC | 2021-04-23 |
| 00724995199142 | Harmony iQ | Harmony iQ 3600 | RLQ3600SLC | 2021-04-23 |
| 00724995163723 | NA | IDSS-SLC Version 8 | XQSLC1 | 2019-02-28 |
| 00724995153083 | NA | IDSS-SLC | XQSLC1 | 2017-06-06 |
| 00724995218799 | Vividimage W 4K | RLM65MG4K3 | RLM65MG4K3 | 2022-08-19 |
| 00724995195113 | Vividimage 4K | RLM314K3 | RLM314K3 | 2021-04-23 |
| 00724995195137 | Vividimage 4K | RLM314K3NPWR | RLM314K3NPWR | 2021-04-23 |
| 00724995195069 | Vividimage D HD | RLM27HD3 | RLM27HD3 | 2021-03-31 |
| 00724995195090 | Vividimage D HD | RLM27HD3NPWR | RLM27HD3NPWR | 2021-03-31 |
| 00724995195106 | Vividimage 4K | RLM314K2 | RLM314K2 | 2021-03-31 |
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