Identity
- Trade Name
- Uretero1 FDA UDI
- Generic Name
- Flexible video ureteroscope, single-use FDA UDI
- Device Name
- The Uretero1 Reverse 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. FDA UDI
- Model / Reference
- URORD101 FDA UDI
- Description
- The Uretero1 Reverse 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. FDA UDI
Identifiers
- Catalog Number
- URORD101 FDA UDI
- Primary DI / UDI-DI
- 00724995209179 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Flexible video ureteroscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.4 Millimeter FDA UDILength — 230 Centimeter FDA UDIWidth — 3 Centimeter FDA UDI
Category: Flexible video ureteroscope, single-use
Uretero1 by Black Diamond Video, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
Cleared under the same submission
K211347 also covers:
K223466 also covers:
K231878 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Black Diamond Video, Inc.
Sources (1)
- FDA UDI 2691ca0f-7ea4-4bf6-a97d-b89a323f27b7 38 fields · synced May 30, 2026