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Reusable Savary Gillard Dilator Bougie Dilator Set

China Reusable Savary Gillard Dilator Bougie Dilator Set, Find details about China Bougie, Bougie Dilator Set from Reusable Savary Gillard Dilator Bougie Dilator Set

Model NO.
JHK
No. of Bougie
6PC
Accesories
Guide Wire, Cleaning Brush
Trademark
Global, Jiuhong, OEM
Transport Package
Cartons
Specification
CE, ISO
Origin
China
HS Code
90189090
Model NO.
JHK
No. of Bougie
6PC
Accesories
Guide Wire, Cleaning Brush
Trademark
Global, Jiuhong, OEM
Transport Package
Cartons
Specification
CE, ISO
Origin
China
HS Code
90189090
1.2  Intended use
It is intended to use for the dilation therapy of digestive tract and cardia stricture.
1.3 Product Classification
    In terms of Rule 5, Annex IX in Medical Device Directive (MDD), Non-sterilized Bougie Dilator Set is an invasive device and the classification is Class I, Sterilized ones belong to Class I*.
1.4 Types
    According to different diameters of Bougie Dilator Set, it can be classified into 16 specifications, including Φ5, Φ6, Φ7, Φ8, Φ9,Φ10, Φ11, Φ12, Φ13, Φ14, Φ15, Φ16, Φ17,Φ18, Φ19 and Φ20.
1.5 Product features
Our Bougie has a medium softness; it can dilate easily and won't bring too much trauma with the smooth anterior taper, it also has stable chemical properties, good biocompatibility.
1.6 Indication
Patients with Esophageal stenosis and cardia stenosis
1.7 Contraindications
Esophagus anastomotic stenosis tumor recurrence; anastomotic stenosis after esophageal surgery in 3 weeks; acute inflammatory period after burn of esophagus; serious hypertension, coronary heart disease, pulmonary incompetence patient, actual situation of patients shall be judged by professional physicians.
1.8 Cautions
(1) Read Instructions for use carefully before use;
 (2) The operators shall be trained physicians;
(3) The product is classified into sterilized and non-sterilized: the sterilized product is single use; while non-sterilized product shall be cleaned and disinfected before use. After application, clean the outer surface of bougie with fluid water and wash the inner bore with injector; wash the guide wire with ultrasonic cleaner.
(4) Dilate with bougie should be slowly and carefully, choose suitable diameter of bougie, do not use too big bougie directly.
(5) Do not use if the bougie appears undesirable phenomenon such as crack and rigidity. Do not use if the bougie has been worn or deformed.
 
    (6) Guide wire shall be checked carefully before use, do not use if there is any damage or corrosion.
  1. 2 Materials
The materials of Bougie Dilator Set should be in accordance with the requirements in Table 1:
Table1 Materials
ComponentMaterialStandard
BougiePVCEN ISO 1060-1-1999
Radiopaque MarkX5CrNi18-10EN10088-1-2005
Guide wireNiti wireASTM F 2063-05
Safety springX5CrNi18-10EN10088-1-2005
Inner Developing PipeX5CrNi18-10EN10088-1-2005
Guide wire is made of Niti wire which has better flexibility and not easy to bend. It is often used for medical instruments and its biocompatibility, safety and reliability has been proven.

Specifications:
ModelO.D.(mm)Length(mm)Characteristics
JHK5,7,9,11,13,15850Each set is equipped with 6 dilators and 1guidewire. With sign of visualization under X-ray and sign of calibration.
 



 

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