Identity
- Trade Name
- HandX Disposables FDA UDI
- Generic Name
- Endoscopic electromechanical surgical system FDA UDI
- Device Name
- HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable FDA UDI
- Model / Reference
- 20-30-008-01 FDA UDI
- Description
- HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable FDA UDI
Identifiers
- Catalog Number
- 20-30-009-01 FDA UDI
- Primary DI / UDI-DI
- 07290017376035 FDA UDI
- FDA Product Code
- GCJ FDA UDINAY FDA UDI
- GMDN Term
- Endoscopic electromechanical surgical system 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
Yes
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
No
FDA UDI
Category: Endoscopic electromechanical surgical system
HandX Disposables by Human Xtensions , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electromechanical surgical system.
- Anovo Surgeon Console — MOMENTIS SURGICAL LTD · Class II
- Anovo Surgeon Console and Anovo Power cable — MOMENTIS SURGICAL LTD · Class II
- Anovo Surgical System (Surgeon Console, RCU and cables) — MOMENTIS SURGICAL LTD · Class II
- Control handle — Dex Surgical · Class II
- Monopolar protection sleeve — Dex Surgical · Class II
- Control Unit — Dex Surgical · Class II
- Control Handle Left — Dex Surgical · Class II
- Arm Monopolar hook — Dex Surgical · 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
- Human Xtensions , Ltd.
Sources (1)
- FDA UDI d356d5a7-06d6-45c9-91d0-0989268c7d8a 34 fields · synced May 30, 2026