1091 ICS Dizcovery

Organization name

Natus Medical Denmark ApS

SRN

DK-MF-000001617

Manufacturer status

Active

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• CW999

  Contraindications • Patients with severe back/neck problems may be excluded for positional tests. • VNG testing may be contraindicated in patients who exhibit the following: blindness, broken nose or other face/head trauma, recent eye surgery and lazy eye. • Any other relevant clinical history or medication of an individual patient should be considered before starting a test. • A medical specialist should be consulted for further information or guidance on clinical conditions that require additional attention before starting the test. • Patients with strong defective vision, ptosis, or abnormal blinks should be tested with caution as these conditions can lead to artifacts. • Patients and users with pacemaker or cardioverter-defibrillator (ICD, WCD and ACD) may be contraindicated as goggles and Insert Panels contain permanent magnets that potentially can affect functionality of such medical devices. There are no side effects to using the ICS Dizcovery system

Primary placement in Denmark; available across 22 countries total.

Trade name

1091 ICS Dizcovery

UDI-DI code

05713315010736

Basic UDI-DI

5713315NA001675V

Reference / catalog number

8-04-16400

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

1091 ICS Dizcovery System

Additional information URL

https://natus.com/support

Clinical sizes

No clinical sizes registered for this device.

• Z12120124VIDEO/ELECTRONYSTAGMOGRAPHS

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