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Reusable HushTM Shielded Bar Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9013S0352
Identity
- Trade Name
- Reusable HushTM Shielded Bar Electrode EUDAMEDKeypoint FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- EMG Electrodes and Accessory Products EUDAMEDReusable HushTM Shielded Bar Electrode FDA UDI
- Model / Reference
- 9013S0352 EUDAMEDFDA UDI
- Description
- Reusable HushTM Shielded Bar Electrode FDA UDI
Identifiers
- Catalog Number
- 9013S0352 FDA UDI
- Primary DI / UDI-DI
- 00382830047920 EUDAMEDFDA UDI
- Basic UDI-DI
- 0382830059169UJ EUDAMED
- 510(k) Number
- K934580 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Ireland 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Reusable HushTM Shielded Bar Electrode by Natus Manufacturing Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0382830059169UJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
- EUDAMED SRN
- IE-MF-000000799
Sources (2)
- EUDAMED 23e7e862-9a8a-4808-8d99-e7ed7f0766bc 61 fields · synced Jul 11, 2026
- FDA UDI c2487135-3e59-44d1-9e07-38afc5be9451 35 fields · synced May 30, 2026