Identity
- Trade Name
- Amendia FDA UDI
- Generic Name
- Nerve-locating system probe, single-use FDA UDI
- Device Name
- Docent Disposable Neuro Monitoring Probe 3mm x 214mm electrode; 50mm wire with DIN42802 connector; OD 3.8mm x ID 3mm x 190mm sheath; 2m extension cable with DIN42802 connector FDA UDI
- Model / Reference
- 4014-00 FDA UDI
- Description
- Docent Disposable Neuro Monitoring Probe 3mm x 214mm electrode; 50mm wire with DIN42802 connector; OD 3.8mm x ID 3mm x 190mm sheath; 2m extension cable with DIN42802 connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375865293 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- GMDN Term
- Nerve-locating system probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Amendia by Technomed Engineering B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Technomed Engineering B.V.
Sources (1)
- FDA UDI 8b84495e-34b6-4d73-82e3-537ae5717ef4 35 fields · synced May 31, 2026