Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Natus Brainwatch System FDA UDI
- Model / Reference
- BWS002 FDA UDI
- Description
- Natus Brainwatch System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830045117 FDA UDI
- FDA Product Code
- OMC FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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
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: Electroencephalograph
Natus by Xltek — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
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- Natus — Natus Neurology Incorporated · Class II
- 128-channel EEG cap (L) — Megin Oy · Class II
- Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
- Zeto ONE Head Unit - Small — ZETO INC · 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
- Xltek
Sources (1)
- FDA UDI 9065f3ca-7f94-432f-98d2-18688889b629 33 fields · synced May 30, 2026