Biovance 3L is a tri-layered, decellularized, dehydrated human amniotic membrane (DDHAM)
• Easy to handle, three layer design allows for suturing if needed
• 10 year shelf life
• Ambient room temperature storage
Biovance 3L is an allograft intended for use as a biological membrane covering that provides an extracellular matrix. As a barrier membrane, Biovance 3L is intended to protect the underlying tissue and create a barrier between the tissue plane boundaries. Indications include, but are not limited to, surgical covering, wrap or barrier, application to partial-and full-thickness, acute and chronic wounds (such as, traumatic and complex wounds, burns, surgical and Mohs surgery sites; and diabetic, venous, arterial, pressure and other ulcers), including wounds with exposed tendon, muscle, bone or other vital structures.
Biovance 3L is contraindicated in patients with a known hyper-sensitivity to Biovance 3L.
If a patient has an adverse reaction related to the use of Biovance 3L, immediately discontinue its use. Biovance 3L should not be used on clinically infected wounds. The pouch contents are sterile if the pouch is unopened and undamaged. Do not use if package seal is broken. Discard material if mishandling has caused possible damage or contamination. Do not resterilize. Biovance 3L must be used prior to the expiration date on the product pouch. Biovance 3L should not be used together with a collagenase product on the wound.
For product information or adverse reaction reporting, telephone l-844-963-2273. All adverse outcomes potentially attributable to Biovance 3L must be reported promptly to Celularity.
Store in a clean, dry environment at ambient room temperature.
Acute Wounds
Burns
Cavity Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Palliative Wounds
Pressure Ulcers
Superficial Wounds
Surgical Wounds
Venous Ulcers
Biovance 3L should not be applied until excessive exudate or bleeding, acute swelling, and infection are controlled. Biovance 3L should not be applied for structural support. Each package of Biovance 3L is intended for use on a single patient on one occasion. Discard any unused portions of Biovance 3L per institutional procedures. No specific orientation (which side is up or down) of Biovance 3L is required. Always handle Biovance 3L using aseptic techniques. The inner pouch is sterile and may be placed in the surgical field; however, the outer pouch is not sterile and should be handled accordingly. Sterile atraumatic forceps should be used to remove Biovance 3L from its inner peel-pouch.
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