Address:3824 Cedar Springs Dr,Dallas,TX,75219,US
Device Description : Areza Antibacterial Alginate with Silver is made of natural alginate fibers deri Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment ideal for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal.Areza Antibacterial Alginate with Silver can restrain the bacteria growing and reduce further bacterial infection. It has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae.
Device Class : U
Duns Number: 047724226
Premarket Exempt : No
Prescription Use : No
Device Description : Areza Antibacterial Alginate with Silver is made of natural alginate fibers deri Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment ideal for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal.Areza Antibacterial Alginate with Silver can restrain the bacteria growing and reduce further bacterial infection. It has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae.
Device Class : U
Duns Number: 047724226
Premarket Exempt : No
Prescription Use : No
Device Description : Areza Calcium Alginate Wound Dressing 4.25" x 4.25" (10) Areza Calcium Alginate Areza Calcium Alginate Wound Dressing 4.25" x 4.25" (10) Areza Calcium Alginate is made of natural fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal.
Device Class : 1
Duns Number: 047724226
Premarket Exempt : Yes
Prescription Use : No
Device Description : Transparent Adhesive Film 2 3/8" x 2 3/4" (100) consist of a thin polyurethane ( Transparent Adhesive Film 2 3/8" x 2 3/4" (100) consist of a thin polyurethane (PU) film, with a hypoallergenic, latex-free, adhesive that gently, yet securely, adheres to skin. They are breathable, sterile, transparent, and water-resistant. May be used as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to external contaminants.
Device Class : 1
Duns Number: 047724226
Premarket Exempt : Yes
Prescription Use : No
Device Description : Showerproof Transparent Adhesive Film 4" x 4.7" consist of a thin polyurethane ( Showerproof Transparent Adhesive Film 4" x 4.7" consist of a thin polyurethane (PU) film, with a hypoallergenic, latex-free, adhesive that gently, yet securely, adheres to the skin. They are breathable, sterile, transparent, and waterproof. May be used as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to external contaminants.
Device Class : 1
Duns Number: 047724226
Premarket Exempt : Yes
Prescription Use : No
Device Description : Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesiv Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone gel sheet made entirely from medical grade silicone. They are effective for the management of both existing and new, hypertrophic or keloid scars. Areza Silicone Gel Sheet for Scars may also be used as a prophylactic treatment on closed wounds to prevent hypertrophic or keloid scarring. Not intended to be used on open, unhealed wounds.
Device Class : 1
Duns Number: 047724226
Premarket Exempt : Yes
Prescription Use : No
Device Description : Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a central polyurethane (PU) foam pad with a size of 4.1” x 4.1” and 5 mm thickness. Foam pad to lay on exuding wounds and is non-adhesive as long as it is used on actively exuding wounds. 2- a very thin PU backing layer which is soft, white in color, breathable, and reinforced with Spunlace, nonwoven fabric mesh. Note: this layer provides water resistance, but it is not waterproof. Meaning liquid may cross from the outer surface to the inside with some delay (normally about 10-20 mins or longer). Unless the foam is soaked, exudate does not cross from the inner surface to outer surface. This dressing is not suitable for showering or swimming. 3- an adhesive layer composed of medical grade Henkel glue that is adhered onto the second layer, the Spunlace, nonwoven fabric mesh.
Device Class : 1
Duns Number: 047724226
Premarket Exempt : Yes
Prescription Use : No
Device Description : Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorp Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self adhesive dressing. The central pad (4"x4") is composed of non-woven viscose fibers which on wound facing surace covered with a fenestrated non-adherent layer. The backing of the dressing (6"x6") is made of polyurethane and Spunlace fabric and is covdered wih adhesives. The non-adherent wound facing layer provides this dressing the unique ability to be used on minimally exuding wounds. This conformable dressing may reduce risk of physical damage and bacterial contamination of wounds. The dressings are individually packed and are sterile.
Device Class : 1
Duns Number: 047724226
Premarket Exempt : Yes
Prescription Use : No
Device Description : Foam dressings are sheets of foamed polymer solutions (most commonly polyurethan Foam dressings are sheets of foamed polymer solutions (most commonly polyurethane) with small, open cells capable of holding fluids. They are layered in combination with other materials. Absorption capability depends on thickness and composition. The area in contact with the wound surface is non-adhesive for easy removal. Available with an adhesive border and/or a transparent film coating that acts as a bacterial barrier. Indicated for partial and full-thickness wounds.
Device Class : 1
Duns Number: 047724226
Premarket Exempt : Yes
Prescription Use : No
Device Description : Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with ant Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic silver particles. The dressing contains 0.35~0.40mg/cm3 (17.3~20.1 mg/100cm2) of ionic silver. The high absorbency, along with antibacterial properties, qualify Areza Medical Silver Foam Dressing as a very useful dressing indicated for exudate absorption and the management of partial to full thickness wounds. The dressing provides proper moist wound healing environment.
Device Class : U
Duns Number: 047724226
Premarket Exempt : No
Prescription Use : Yes