Medical Silicone Gel Sheet--Guangzhou Wanhe Plastic Material Co.,Ltd

Medical Silicone Gel Sheet

Technical requirement number of medical device: Guangdong FDA 20172140227
Registration number of product:
Guangdong FDA 20172140227
Production license number: Guangdong FDA 20010347
Advertisement Approval No.:
Guangdong FDA Advt. (Text) No. 260829-00626
Indication:

Apply to the scar on the human body surface for the auxiliary treatment of scar protection.

Medical Silicone Gel Sheet

Method of use:
The product shall be used after wound healing or taking out stitches. Before use:
1)Firstly, clean the scar area;
2)Then carefully remove the isolation film in the back of the sheet, and apply the sticky side to the scar area.

Type	Spec.	Length (mm)	Width (mm)	Thickness (mm)
Rectangular	30�?0	80±4mm	30±2mm	1.5±0.5mm
	80�?20	120±5mm	80±4mm
	30�?20	120±5mm	30±2mm
	30�?60	160±5mm	30±2mm
	30�?00	200±5mm	30±2mm
	50�?40	240±5mm	50±2mm
	100�?40	240±5mm	100±2mm
	60�?20	120±5mm	60±2mm
	120�?50	150±5mm	120±2mm
	120�?10	210±5mm	120±5mm
	30�?50	150±5mm	30±2mm
	25�?20	120±5mm	25±2mm
Cambered	35�?50	150±5mm	35±5mm	1.5±0.5mm

Type	Spec.	Outer Diameter (mm)	Inside Diameter (mm)	Thickness (mm)
Circular	R60	Φ60±5mm	Φ20±2mm	1.5±0.5mm
Circular	R80	Φ80±5mm	Φ20±2mm	1.5±0.5mm

Contraindications, precautions, warnings and suggestive notes:

1) Do not use in case of unhealed scar, secretion, or inflammation and infection in the wound;

2) Shall be used under the guidance of a doctor;

3) For external use only;

4) Forbidden for allergic constitution;

5) Stop use immediately when any allergy occurs during the application;

6) Can use the thin elastic gauze or tape to fix it while sleeping or doing strenuous exercises;

7) Medical silicone gel sheet can be reused. Keep the sticky side surface clean in use. Avoid the adhesion of too many impurities which may lead to a loss of viscosity; Keep the product structure integrity in use; Avoid a product break by excessive pulling; Wash with warm water when the sheet is dirty and reuse after drying.

8) The inner packing is a PET case. The outer packing is a paper box.

9) Keep it out of reach of children when not in use.

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