Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Articulated arm with L-Column, with central one hand fixation, 40 cm FDA UDI
- Model / Reference
- 118970FX FDA UDI
- Description
- Articulated arm with L-Column, with central one hand fixation, 40 cm FDA UDI
Identifiers
- Catalog Number
- 118970FX FDA UDI
- Primary DI / UDI-DI
- 04250407786670 FDA UDI
- FDA Product Code
- FWZ FDA UDI
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument assist arm system, manually-adjusted
Fentex by FENTEX medical GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ASSISTO® Arm-System — Geomed Medizin-Technik GmbH & Co. KG · 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 I | Pending data |
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Manufacturer
- Manufacturer
- FENTEX medical GmbH
Sources (1)
- FDA UDI 1562fb0f-b85f-4c61-b96f-4fae846b838a 35 fields · synced Jun 8, 2026