Identity
- Trade Name
- HandX FDA UDI
- Generic Name
- Endoscopic electromechanical surgical system FDA UDI
- Device Name
- The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use. FDA UDI
- Model / Reference
- 20-30-019-01 FDA UDI
- Description
- The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use. FDA UDI
Identifiers
- Catalog Number
- 20-30-019-01 FDA UDI
- Primary DI / UDI-DI
- 07290017376004 FDA UDI
- FDA Product Code
- NAY FDA UDIGCJ 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
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: Endoscopic electromechanical surgical system
HandX by Human Xtensions , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 441008c1-01fc-44ce-9ad7-80526434b0e3 35 fields · synced May 30, 2026