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Mira

FDA UDI

Class II (US FDA UDI)

by Virtual Incision

Identity

Trade Name
MIRA FDA UDI
Generic Name
Robotic surgical arm system FDA UDI
Model / Reference
180-040000-000 FDA UDI

Identifiers

Primary DI / UDI-DI
00850038042042 FDA UDI
510(k) Number
DEN230025 FDA UDI
FDA Product Code
SAB FDA UDI
GMDN Term
Robotic surgical arm system 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Robotic surgical arm system

Mira by Virtual Incision — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical arm system.

Cleared under the same submission

DEN230025 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Virtual Incision

Sources (1)

  • FDA UDI 56215739-0644-46e0-b5e6-d7d8f314028b 33 fields · synced May 30, 2026