Model NO. | CSB, CSC | After-Sale Service | Return and Replacement |
Instrument Classification | Class II | Product Name | Disposable Circular Stapler |
Shelf Life | 3 Years | Certificate | CE ISO13485 |
Transport Package | White Box + Carton Box | Specification | Outer Diameter 32mm, 34mm |
Trademark | Weiyuan | Origin | Jiangsu, China |
HS Code | 9018909919 | Production Capacity | 1000 Piece/Pieces Per Day |
Product Name
|
Disposable Anorectal Stapler (PPH)
|
Appearance
|
Smooth appearance, soft, clear outline, no
burr, flying edge, scratches, shrinkage, and
other defects
|
Performance
|
·The anastomotic nail shall be stable in the
assembly without bad deformation, and the
nail shall not be exposed on the surface of
the nail bin after swinging;
·The safety device of the stapler should
be flexible in opening and closing under
firing conditions;
·The reset spring should be elastic
enough to reset quickly when the handle
is released;
·Stapler should have good anastomosis and
cutting performance. After anastomosis,
the anastomosis nail should be b-shaped,
the ring knife should not have a rolled
edge or a broken edge;
·After the anastomosis, the anastomosis
should be able to withstand a pressure of
not less than 3.6kpa, and the water
leakage should not exceed 10 drops within
15 seconds;
·The pressure resistance of the expander
should be ≥35N;
·The annular blade should be sharp and
the cutting force should not be greater
than 0.8N;
·The tensile strength of the material
made of anastomotic nails should not be
less than 240Mpa.
|
Package
|
The package shall be in good condition and
there shall be no channels or holes in the
bonded sealing area
|
Sterility
|
Sterilized with ethylene oxide
|
Residual EO
|
After sterilization with ethylene oxide, the
residual ethylene oxide should not be more
than 10μg/g
|