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Neuro Omega with Neuro Omega Drive Headstage
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref NOW-020021-00
Identity
- Trade Name
- Neuro Omega with Neuro Omega Drive Headstage EUDAMEDFDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- Neuro Omega EUDAMED
- Model / Reference
- NOW-020021-00 EUDAMEDNeuro Omega with Neuro Omega Drive Headstage FDA UDI
Identifiers
- Catalog Number
- NOW-020021-00 FDA UDI
- Primary DI / UDI-DI
- 27290114063856 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011406123MERNOQ5 EUDAMED
- 510(k) Number
- K171581 FDA UDI
- FDA Product Code
- GZL FDA UDI
- EMDN Code
- N010199 NEUROPHYSIOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Depth electrode FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1330 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
Category: Depth electrode
Neuro Omega with Neuro Omega Drive Headstage by Alpha Omega Engineering Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K171581 also covers:
- Autoclavable Drive — Alpha Omega Engineering Corp.
- Autoclavable Drive — Alpha Omega Engineering Corp.
- Neuro Omega — Alpha Omega Engineering Corp.
- Neuro Omega — Alpha Omega Engineering Corp.
- Neuro Omega Autoclavable Drive Headstage — Alpha Omega Engineering Corp.
- Neuro Omega Autoclavable Drive Headstage KIT — Alpha Omega Engineering Corp.
- Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable) — Alpha Omega Engineering Corp.
- Neuro Omega Drive Headstage — Alpha Omega Engineering Corp.
- Neuro Omega Drive Headstage Kit — Alpha Omega Engineering Corp.
- Neuro Omega Drive Headstage Kit — Alpha Omega Engineering Corp.
- Neuro Omega ECOG HeadBox Kit — Alpha Omega Engineering Corp.
- Neuro Omega ECOG HeadBox Kit — Alpha Omega Engineering Corp.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alpha Omega Engineering Corp.
Sources (2)
- FDA UDI 8e9fc022-1e1d-4a84-9ffa-5dc6ae3063cc 34 fields · synced Oct 7, 2026
- EUDAMED b9372303-a3f8-46ad-8eb9-d3d08184a491 61 fields · synced Oct 7, 2026