Single Use Bite Block, Mouth Pieces for Gastroenterology with Ce

• Type: Disposable Medical Supplies
• Material: Polyethylene
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult or Children
• Logo Printing: Customized
• Model NO.: JHY-KD
• Certification: CE, SGS, FDA, ISO13485, Cmdcas
• Color: Green/White/Yellow/ Blue
• Strap: Rubber/ Woven
• Pouch: Paper & Plastic
• Transport Package: Cartons
• Specification: FDA, CE, ISO
• Trademark: Jiuhongmed
• Origin: Jiangsu Changzhou
• HS Code: 9018909010
• Production Capacity: 2, 000, 000 PCS

Product Description

Single Use Bite Block, Mouth Pieces for Gastroenterology with CE


Product Description:

1. Intended Use:
It is used to protect oral cavity and gastroscope in the process of gastroscope operation.


 2. Materials
 

Component	Material	Standard
Bite block body	Polyethylene	ISO 1872-1-1993
Strap	Non-latex rubber belt	ISO 23529-2010

3. Characteristics: 

* Superior design
* Smooth skin to enhance patient comfort
* Large and flexible openings allowing the scope passage and finger-assisting simultaneously
* Strap available to improve safety and convenience

4. Specification
 

Model	Description
JHY-KD-A1	Disposable, without strap, suitable for adult
JHY-KD-B1	Disposable, with strap, suitable for adult
JHY-KD-C1	Disposable, with strap, suitable for pediatric

5 Brief introduction
    Disposable Bite Block is mainly used to the protection of oral cavity and gastroscope in the process of gastroscope operation. It is widely used in clinical application, the Disposable Bite Block produced by our company has a nice appearance, accords with human body engineering, structure firmly and can meet clinical requirements. The product is mainly made up of bite block body and strap.
1.2 Intended use
It is used to protect oral cavity and gastroscope in the process of gastroscope operation.
1.3 Product Classification
    In terms of Rule 5, Annex IX in Medical Device Directive (MDD), Disposable Bite Block is an EO sterilized and invasive device, the classification is Class Is.
1.4 Types
As per the different structures, it is classified into two types, including with strap and without strap type, and the structure with strap is composed of bite block body and strap.
As per the different users, it is classified into adult and pediatric type.
1.5 Product features
    Disposable Bite Block accords with human body engineering, and structure firmly.
1.6 Cautions
(1) Do not use the instrument when package is damaged.
(2) Do not use the instrument if the valid period is exceeded.
(3) The product is sterile, single use only, dispose after use and reuse is forbidden.
(4) The instrument shall be operated by trained medical staff.
2 Materials
The materials of Disposable Bite Block should be in accordance with the requirements in Table 1:
 
 
 
Table1    Materials

Component	Material	Standard
Bite block body	Polyethylene	ISO 1872-1-1993
Strap	Non-latex rubber belt	ISO 23529-2010