[Product Name]:

 Eyelid Opener

[Model/Specification]:

 Fixed sealing type, fixed eyelash cover type, infant and toddler type, translational eyelash cover type, steel wire open type, steel wire eyelash cover type.

[Name of Filing Person/Production Enterprise]: 

Suqian Shengshi Medical Equipment Co., Ltd

[Name and Address of Filing Person/Production Enterprise]: 

No. 36 Shuanggou West Road, Sihong County Economic Development Zone

[Production Address]: No. 36 Shuanggou West Road, Sihong County Economic Development Zone

[After sales Service Unit] 

Suqian Shengshi Medical Equipment Co., Ltd

[Production Filing Certificate No.] Susu Food and Drug Supervision Instrument Production Preparation No. 20194005

[Medical Device Filing Certificate Number]

[Product Technical Requirements Number]

The performance, structural composition, and scope of application of the product are composed of a head and a handle, with a round and blunt head end. There are plate type, steel wire type, translational type, fixed type, and rotary rod type. Made of 06Cr19Ni10 material specified in GB/T 1220-2007, TC4 material specified in GB/T 3621-2007, and titanium wire material specified in GB/T 3623-2007. Non sterile provision. The product has good corrosion resistance, a smooth surface, and is sterilized by the user according to the instructions before use. Used to expand and support eye tissue.

[Contraindications] None

[Precautions ]

During high-pressure steam sterilization, it must not be closed or collide with other objects, otherwise it will affect the sterilization effect. In addition, during high-pressure steam sterilization, thermal expansion can also cause the connection to break. Used by professional medical personnel.

[Warning]

1. It is strictly prohibited to use the eyelid opener when it deforms, breaks, or rusts;

2. Non professionals are strictly prohibited from repairing deformed eyelid openers.

[Instructions for Use]

1. High temperature and high pressure sterilization is required before use of the product;

2. After use, the eyelid opener should be cleaned promptly.

[Product maintenance and upkeep methods]

1. After the surgery, the remaining stains on the eyelid opener should be washed clean and dried for later use.

2. The eyelid opener should be stored in a box with soft materials as padding to prevent collision between the eyelids and damage to the head of the opener.

[Storage]

The eyelid opener should be stored indoors with a relative humidity of no more than 80%, no corrosive gases, and good ventilation.

[Production Date] 

Please refer to the label for details

[Service life]

8 years