Tongue depressor,wooden,disp/BOX-100

GENERAL DESCRIPTION
Tongue depressor.

INTENDED USE
A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.

TECHNICAL SPECIFICATIONS
Finely polished smooth splinter free wood.
With rounded extremities for depressing the tongue during examination of the patient's mouth and the throat.
Width: 14-18mm
Length: 120-160mm
Thickness: 1.8-2.2mm
Single use
Nonsterile
Primary packaging: Box of 100 pieces

SHELF LIFE
Five years.

ENVIRONMENTAL CONDITIONS
Storage conditions: 0 - 50°C / < 65% RH.
Operating conditions: 10 - 40°C / < 65% RH.

WEIGHT AND VOLUME (Packaged)
Weight: 260 gr.
Volume: 0.50 dm³.

INSTALLATION / COMMISSIONING REQUIREMENTS
No installation or commissioning requirements.

TRAINING REQUIREMENTS
No user training will be required.

MAINTENANCE/USER REQUIREMENTS
No maintenance requirements.

COMPONENT OF A KIT
S9901030 - IEHK2017,kit,suppl.3-renewable

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
Self-declared CE under the EU MDR 2017/745 as Class I device.

NOMENCLATURE
GMDN Code: 42461