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Organization name
UDI-DI code
Reference / catalog number

HUSH Reusable Shielded Cables for… — Class I MDR

MD Atlas
Natus Manufacturing Limited

EUDAMED last updated this device on Oct 29, 2021

HUSH Reusable Shielded Cables for EMG & IOM

0382830058797VE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Manufacturing Limited
UDI-DI code: 00382830047845
Reference / catalog number: 9013C0112

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Manufacturer information

Organization name: Natus Manufacturing Limited
SRN: IE-MF-000000799
Manufacturer status: Active

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Consult instructions for use

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: HUSH Reusable Shielded Cables for EMG & IOM
UDI-DI code: 00382830047845
Basic UDI-DI: 0382830058797VE
Reference / catalog number: 9013C0112
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: HUSH™ Shielded Cable, 1 m. EMG cables are used to connect electrodes with amplifiers in order to stimulate or record the electrical activity to or from muscles and motor and sensory nerves during nerve conduction studies, evoked potential studies, or inter-operative monitoring.
Additional information URL: https://neuro.natus.com/neuro-support
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N010101ELECTROMYOGRAPHIC ELECTRODES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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