Biopsy Punch 3 Indications for Use/Target Users 1.1 Sterile, Single Use, Disposable Biopsy Punch is a sharp rounded stainless steel blade attached to a pencil-like handle, available in a variety of sizes for obtaining skin specimens for biopsy. 2.1 The sterile, single-use Biopsy Punch is designed for obtaining diagnostic full-thickness skin specimen or removal of skin specimen for biopsy procedure. 3.1 The device is designed for use by a qualified surgeon, doctor, or paramedic. 3.2 The device is indicated for use with the general patient population. 4.1 Ergonomic plastic handle. 4.2 Different sizes for different thickness of tissues and operating visibility. 5.2 Always check the integrity of product, packaging, and expiration date before use. 5.3 Use product immediately after opening. 5.4 For single-patient-use only. Use once and destroy. 5.5 If reused, this device can become a carrier for communicable disease, HIV, Hepatitis, contagious diseases, or other undue diseases to patient and/or user. 5.6 Devices are extremely sharp, use care while handling. 5.7 Care must be taken so that the pouch is not opened in an unsterile area, otherwise the sterilized blade will become unsterile. 5.8 The sterility of each device is guaranteed until opened or damaged. 5.9 Re-sterilization or reuse of the device can cause a change in the mechanical properties and material used. 5.10 Re-sterilization or reuse of the device may note meet the intended use as the device may be blunt. 5.11 Re-use of device can work as a carrier for communicable disease to patient and/or user. 5.12 Adverse event may occur if device is used after expiration date as it is the same as the sterility expiration date. 6.1 There are no recognized contraindications for the use of the Biopsy Punch. 7.1 The Biopsy Punch is sterilized by Gamma Radiation (indicated by I ETERILE IR ) single use only. 7.4 Inspect each package prior to use. 7.5 Do not use the component if any seal or cavity is damaged ® or breached or if the expiration date has been exceeded. Once opened the component must be used or discarded. U.S Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

Graphic Symbol Legend for Medical Device Labeling 8 Operating Instructions 8.1 Select proper type and size of Biopsy Punch according to the procedure, always use bigger size for thick tissue and smaller for fine soft tissue. 8.2 Choose the site for taking the skin specimen. 8.3 After selection clean the site with proper disinfectant. 8.4 Hold the Punch between the thumb, index and middle finger while stretching the skin with the fingers of the other hand. 8.4.1 This method of holding ensures the precise guiding of the instrument, so that the selected tissue can be removed in one, well-targeted...