Disposable Savary Gillard Dilator Bougie Dilator
|FOB Price:||US $295 / Piece|
|Min. Order:||1 Piece|
|Min. Order||FOB Price|
|1 Piece||US $295/ Piece|
|Payment Terms:||T/T, Western Union, Money Gram|
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- Model NO.: JHK
- Material: Plastic
- Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
- Group: Adult
- O.D: 5-12mm
- Trademark: Global, Jiuhong, OEM
- Specification: CE, ISO
- HS Code: 90189090
- Type: Endoscopic Device
- Certification: CE, ISO13485
- Quality Guarantee Period: Two Years
- Logo Printing: With Logo Printing
- Mark: with
- Transport Package: Cartons
- Origin: China
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*.
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.
Patients with Esophageal stenosis and cardia stenosis
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) 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.
- 2 Materials
|Bougie||PVC||EN ISO 1060-1-1999|
|Guide wire||Niti wire||ASTM F 2063-05|
|Inner Developing Pipe||X5CrNi18-10||EN10088-1-2005|
|JHK||5,7,9,11,13,15||850||Each set is equipped with 6 dilators and 1guidewire. With sign of visualization under X-ray and sign of calibration.|