650.000000

Organization name

AKRUS GmbH & Co. KG

SRN

DE-MF-000005262

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260647941586

Basic UDI-DI

426064794SCSB5010surgeS8

Reference / catalog number

650.000000

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The mobile, electrically operated operating tables are designed for placement and positioning of patients in the required posture during diagnostic and therapeutic procedures as well as during surgical interventions on humans. The product enables optimal access to the patient's head in its various positions and is intended for use in the following medical fields: • Ophthalmology • ENT (ear, nose and throat) • Oral and maxillofacial surgery • Plastic, reconstructive and aesthetic surgery, primarily in the head area • Dentistry • Dermatology • Nerve stimulation • Blood donation Due to its design, functionality and accessories, the surgical chair only allows the following positioning of patients: • Supine position • Sitting position • Beach chair position • Prone position • Shock position: Zero position and Trendelenburg position. The surgical chair is designed for patients weighing a maximum of 200 kg or 300 kg, depending on the variant. The headrest is designed to support a maximum weight of 20 kg. The operating tables are only intended for positioning patients immediately before, during and after a procedure/surgical intervention and for short-distance transportation for transfer purposes along with a safety rail or patient fixation belt. Positioning may only be carried out by appropriately trained specialist personnel. The product is suitable for use in the immediate controlled patient environment. The essential performance of the product is given by no movement during first error situations.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12011201OPERATING CHAIRS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification