Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- XACT ACE Robotic System FDA UDI
- Model / Reference
- D FDA UDI
- Description
- XACT ACE Robotic System FDA UDI
Identifiers
- Catalog Number
- XR-ACE-SYS FDA UDI
- Primary DI / UDI-DI
- 07290017702254 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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
Category: Robotic surgical arm system
Ace by Xact Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
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
- Xact Robotics Ltd
Sources (1)
- FDA UDI 5826ea38-e084-4467-9a2d-be9f96f6aac2 35 fields · synced May 31, 2026