Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- Reusable Shielded Cable, for concentric and single fiber EMG needle electrode; 1.25 m FDA UDI
- Model / Reference
- 085-444700 FDA UDI
- Description
- Reusable Shielded Cable, for concentric and single fiber EMG needle electrode; 1.25 m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375868089 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- Not 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
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 1250 Millimeter FDA UDI
Natus 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 b1600ee4-0544-4838-983e-423b9232beef 36 fields · synced May 30, 2026