Maiden Biosciences Topical Collagen Sheet Dressings

Maiden Biosciences Topical Collagen Sheet Dressings are absorbent microfibrillar type I bovine collagen intended for the management of moderately to heavily exuding wounds and the control of minor bleeding. Provides a physiologically favorable environment that encourages wound healing. Applied directly to the wound where it begins to absorb the exudate that may impair tissue regeneration and work as a hemostatic agent to control minor bleeding. Supplied sterile and for single use only.

Maiden Biosciences

Maiden Biosciences, Inc. is a biotechnology company that specializes in the development, manufacture and distribution of biologic combination medical devices for advanced wound care management, including topical collagen sheets and pellet wound care dressings.

Website: www.maidenbio.com

Indications

Maiden Biosciences Topical Collagen Sheet Dressing is indicated for the management of moderately to heavily exuding wounds and to control minor bleeding.
Maiden Biosciences Topical Collagen Sheet Dressing may be used for the management of exuding wounds such as: pressure injuries, venous stasis ulcers, diabetic ulcers, acute wounds, e.g., trauma and surgical wounds and partial-thickness burns.

Contraindications

Do not use on patients with a known allergy or sensitivity to bovine collagen.

Warnings and Precautions

For topical use only. Not for ophthalmic use. Avoid eye contact.

Adverse Effects/Reactions

Some reactions such as transitory pain, bleeding, blistering, swelling and redness have been reported in isolated cases using a similar product. If these conditions continue for more than three to five days, discontinue use of the product and notify physician.

Storage Requirements

Temperature limitations: Storage at ambient room temperature and keep dry. Sterile single use. Do not reuse.

How Supplied/Sizing

1"x1", 2"x2", 4"x4", 7"x7", 10"x11", 10"x22". 30 per box.

HCPCS Code

A6021

A6023

Product features

cancel Antimicrobial format available

check_circle Compatible w/ topicals

cancel Conforms readily to wound

check_circle Cuttable

cancel Flexible

check_circle Gels on contact w/ exudate

cancel Limited shelf life

cancel Moldable

cancel Powder

cancel Rope

check_circle Secondary dressing required

cancel Silicone-based adhesive

cancel Usable on infected wounds

check_circle Variety of sizes

Other features

cancel Educational Material Available

check_circle Free Samples/Trials Available

cancel Published Clinical Article Available

Recommended Use

Acute Wounds
Burns
Chronic Wounds
Deep Wounds
Diabetic Foot
Moderate/Highly Exudating Wounds
Pressure Ulcers
Surgical Wounds
Traumatic Wounds
Venous Ulcers

Mode of Use/Application

Please use under the guidance of a health care professional.
Prepare Wound Site and Surrounding Skin:
Cleanse wound with advised liquid to remove residue according to local infection control protocol. Deep wounds should be well irrigated. Skin around wound should be clean and dry.
To Apply:
Apply medication to the wound, if indicated. Apply the collagen dressing to the entire wound surface. Cover with secondary dressing.

Removal & Change Frequency

Dressing may be left in place for up to seven days.
Change the dressing if drainage seeps through the back of the dressing, or if the edge of the dressing becomes loose; or if the condition of the wound or surrounding skin causes concern; or as directed by a qualified health care professional.
Dressing may be moistened to ease removal.
Carefully remove adhesive dressings by holding the edge of the dressing and slowly pulling it parallel to the skin.
Dispose of in accordance with local guidance.

Additional Recommended Dressings

Cover with secondary dressing.

Construction

• 100% bovine collagen, primarily Type I, certified BSE free, with no fillers.
• United States sourced, processed, packaged and sterilized.
• Produced under a FDA 510k, medical device; perscription only.
• Certified as ISO 9001:2015 and/or ISO 13485:2016
• Assigned HCPCS reimbursement codes for Medicare/Medicaid
• Packaged in Tyvek® and poly, single use sterilized packaging.
• Five-year shelf life.
• Provides physiologically favorable environment that encourages healing

Clinically Tested

Non-allergenic
Non-comedogenic
Non-cytotoxic
Non-irritating

Technical Specifications

Latex free, 100% bovine collagen, primarily type I, certified BSE free, with no fillers.

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