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Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots
FDA UDIIdentity
- Trade Name
- Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Model / Reference
- Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots FDA UDI
Identifiers
- Catalog Number
- NOW-DFF000-00 FDA UDI
- Primary DI / UDI-DI
- 27290114060787 FDA UDI
- 510(k) Number
- K171581 FDA UDI
- GMDN Term
- Depth electrode FDA UDI
Classification
- 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
Yes
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
Hydrogen Peroxide FDA UDI
Category: Depth electrode
Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots by Alpha Omega Engineering Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Alpha Omega Engineering Corp.
Sources (1)
- FDA UDI 6a7ffd3f-f1c3-437b-a3c4-cecc61acd439 34 fields · synced Jun 8, 2026