Identity
- Trade Name
- Vision1 FDA UDI
- Generic Name
- Endoscopic video image display unit FDA UDI
- Device Name
- The Vision1 Imaging Console and Display System is used exclusively with the Uretero1 Ureteroscope System. FDA UDI
- Model / Reference
- VIS101 FDA UDI
- Description
- The Vision1 Imaging Console and Display System is used exclusively with the Uretero1 Ureteroscope System. FDA UDI
Identifiers
- Catalog Number
- VIS101 FDA UDI
- Primary DI / UDI-DI
- 00724995209186 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Endoscopic video image display unit 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
- Width — 3 Centimeter FDA UDILength — 230 Centimeter FDA UDIOuter Diameter — 2.4 Millimeter FDA UDI
Category: Endoscopic video image display unit
Vision1 by Black Diamond Video, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image display unit.
- Insighters — Shenzhen Insighters Medical Technology Co., Ltd. · Class I
- CuratOR — EIZO CORPORATION · Class I
- NDS — PENTAX of America, Inc. · Class I
- Insighters — Shenzhen Insighters Medical Technology Co., Ltd. · Class I
- Ambu aView™ 2 Advance — Ambu A/S · Class I
- CuratOR — EIZO CORPORATION · Class I
- Karl Storz — EIZO CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Black Diamond Video, Inc.
Sources (1)
- FDA UDI 7278323e-8763-4453-a778-91089533d326 38 fields · synced Jun 1, 2026