LEFT SAM·MAS KIT

Organization name

VEC MEDICAL SPAIN, S.L.

SRN

ES-MF-000002992

Manufacturer status

Active

10 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  Disinfect the device with medical specific instrument disinfectant after each use to avoid the risks of contamination and infection in the patient. The immersion time of the device depends on the disinfectant used. After disinfection, remove the disinfectant products with water and dry the device meticulously.
• CW999

  Dental trays and forks are for single use, do not reuse. To reuse them may cause infection
• CW999

  The dental trays and forks do not have any functionality on their own, they must be used together with the device.
• CW999

  Do not use if the product is damaged.
• CW999

  The recommended number of device uses is 100.
• CW999

  The product should only be used by skilled health professionals trained in the technique.
• CW999

  Do not use outside of its indicated use.
• CW999

  CONTRAINDICATIONS: Absence of dental support, limited protrusive movement, severe temporomandibular disorder or presence of fixed orthodontics.

Primary placement in Spain; available across 6 countries total.

Trade name

LEFT SAM·MAS KIT

UDI-DI code

08436570232183

Basic UDI-DI

84365702328TE

Reference / catalog number

28001_L-kit

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

Mandibular Advancement Selector. The SAM·MAS® is a Mandibular Advancement Selector device with multiple uses for different patients. The device requires single-use accessories that are attached for use and detached when no longer needed. Its design and geometry allow it to be attached to the patient's mouth and manipulate the jaw in terms of protrusion/retrusion and mouth opening.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Left

• Q03010299ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER

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