Identity
- Trade Name
- MIRA FDA UDI
- Generic Name
- Robotic electrosurgical instrument, bipolar, single-use FDA UDI
- Model / Reference
- 180-050000-101 FDA UDI
Identifiers
- Catalog Number
- MIRA-SUD-BPG FDA UDI
- Primary DI / UDI-DI
- 00850038042059 FDA UDI
- 510(k) Number
- DEN230025 FDA UDI
- FDA Product Code
- SAB FDA UDI
- GMDN Term
- Robotic electrosurgical instrument, bipolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4962 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
No
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
MR Unsafe FDA UDI
Category: Robotic electrosurgical instrument, bipolar, single-use
Mira by Virtual Incision — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic electrosurgical instrument, bipolar, single-use.
- Single-Site — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- da Vinci Energy — Intuitive Surgical, Inc. · Class II
- EndoWrist;daVinci Si — Intuitive Surgical, Inc. · Class II
- da Vinci Energy — Intuitive Surgical, Inc. · Class II
- Single-Site; daVinci Si — Intuitive Surgical, Inc. · Class II
- Single-Site — Intuitive Surgical, Inc. · Class II
- Endowrist — Intuitive Surgical, Inc. · Class II
Cleared under the same submission
DEN230025 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
- Virtual Incision
Sources (1)
- FDA UDI 15100118-850d-4997-8216-47e6949dc711 34 fields · synced May 30, 2026