Identity
- Trade Name
- HandX Needle Holder 5mm FDA UDI
- Generic Name
- Endoscopic electromechanical surgical system FDA UDI
- Model / Reference
- 20-30-011-01 FDA UDI
Identifiers
- Catalog Number
- 20-30-014-01 FDA UDI
- Primary DI / UDI-DI
- 07290017376028 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDI
Category: Endoscopic electromechanical surgical system
HandX Needle Holder 5mm 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 a1d7d543-edaa-49db-a54c-4b8188aea149 34 fields · synced May 29, 2026