Identity
- Trade Name
- XACT ACE Xtend Remote FDA UDI
- Generic Name
- Computer/medical device keyboard FDA UDI
- Device Name
- XACT ACE Xtend Remote FDA UDI
- Model / Reference
- A FDA UDI
- Description
- XACT ACE Xtend Remote FDA UDI
Identifiers
- Catalog Number
- PR06ASA057003 FDA UDI
- Primary DI / UDI-DI
- 07290017702377 FDA UDI
- 510(k) Number
- K221116 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Computer/medical device keyboard 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Computer/medical device keyboard
XACT ACE Xtend Remote by Xact Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Computer/medical device keyboard.
- PENTAX Medical — HOYA CORPORATION · Class II
- KEYBOARD — Olympus Medical Systems Corporation · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- KEY BOARD — Olympus Medical Systems Corporation · Class II
- KEYBOARD — Olympus Medical Systems Corporation · Class II
- KEYBOARD — Olympus Medical Systems Corporation · Class II
- VISERA VIDEO SYSTEM CENTER — Olympus Medical Systems Corporation · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
Cleared under the same submission
K221116 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
- Xact Robotics Ltd
Sources (1)
- FDA UDI 35171def-185d-48e2-b53b-5b4dfc689075 36 fields · synced May 30, 2026