BIODERM SCIENCES, INC.
9 Industrial Park Dr., Suite 103
Oxford, MS 38655
Ph 662-234-5243
Fax 662-234-5412
info@biodermsciences.com

Wound Solution


BioDerm Sciences' Wound Solution is an acidic, zinc-saline, wet dressing for external wound management. It is sterile and supplied sterile in 50 ml injection bottles with Teflon septa and aluminum crimp caps. The dressing is applied by withdrawing the contents from the injection bottle with a syringe. The crimp caps have a pull-tab, which must be removed prior to use, and signifies whether the bottle has been opened or not. The contents must be used within five days after opening.

This aqueous solution contains small amounts of zinc salt, iron sulfate, and a trace amount of sulfuric acid to help adjust the pH to a value of 2.9. The solution is not buffered. BioDerm Sciences' Wound Solution is intended to cleanse, irrigate and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and full-thickness wounds, burns and ulcers (diabetic, venous stasis, pressure). Its non-irritating formulation can be used on mucous membranes. It may also be used as a wound cleanser to remove foreign matter, bacteria, and tissue debris.

The device is intended for use in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).

BioDerm Sciences' Wound Solution is contraindicated in the following cases: (1) known or suspected allergic reactions to this dressing or its components; (2) third degree burns; and (3) any wound for which the dermis has been severely damaged or is missing.

510(k) Summary