Shield - U.S. Product Details and Resources

Kerecis Shield is an intact fish skin for the management of chronic wounds such as diabetic wounds, pressure ulcers, vascular ulcers, and draining wounds, which are commonly treated in physicians’ private offices.

The Kerecis fish-skin grafts contain fat, protein, elastin, glycans, and other natural skin elements and are supplied in multiple shapes, variants, and sizes. The product integrates the Kerecis intact fish skin with a silicone contact layer.

Shield is fenestrated to allow adequate wound drainage for appropriate wound moisture at the wound bed.

The product classifies as a medical device and consists of intact fish skin processed using Kerecis’ proprietary EnviroIntact™ method. The product is not subject to the May 31, 2021, FDA 351 regulation.

Product information

Manufacturer Name

Kerecis Limited

Product Name (s)

Shield Standard, Shield Adhesive, Shield Spiral

Brand Name

Shield

Generic Name

Fish Skin with Silicone Cover Product Material: Sheet

HCPCS Code

A2019

A2019 HCPCS Code Listed Product Description

erecis omega3 marigen shield, per square centimeter

FDA Registration

K213231

FDA Clearance Date

June 29, 2022

FDA Clearance Type

510(K)

First Marketing Date

June 29, 2022

Unit for Strength

SQ CM / Each

Number of Items per Package

Number of Items per Alternate ID

Units of Volume per Item for all Alt ID’s

Product Code	Shield Product Description – Size	Total Size cm2	Billable Units	HCPCS Code	UPC
50215I53B0D	Shield Standard – 50 mm Circular, Diameter	19.64	20	A2019	5694310964319
50215I52B0D	Shield Adhesive – 30 mm Circular, Diameter	7.07	8	A2019	5694310963770
50215H51B0D	Shield Adhesive – 20 mm Circular, Diameter	3.14	4	A2019	5694310963756
50215K52B0D	Shield Spiral – 30 mm Diameter Circular	7.07	8	A2019	5694310964364
50215H50B0D	Shield Adhesive – 15 mm circular, diameter	1.77	2	A2019	694310965187
50215L54B0D	Shield Spiral – 80 mm circular, diameter	50.27	51	A2019	5694310965217

Additional Information

Important Information

This website and its content is not intended to provide diagnosis, treatment, or medical advice. Products, services, information, and other content provided on this website, including information provided directly or through links to third-party websites, are for informational purposes only. Information on this website should not be considered a substitute for professional advice from a healthcare provider. Always consult with a physician or other healthcare professional regarding any medical or health-related diagnosis or treatment options.

Products and their variations may not be available in all countries and could be known under different trade names. Products, product names, indications, and claims vary by jurisdiction. Always verify with your local healthcare professional and consult the printed package information before use. Information on this website may not be current and might not reflect the latest product labeling – please refer to latest IFU’s on the website. For questions about product availability, please contact your Kerecis representative or use the contact form on our website.

Products are derived from fish sources and should not be used in patients with a known allergy to fish or sensitivity to fish products. Note that fish allergy is distinct from shellfish allergy. Do not apply fish skin products over infected or deteriorating wounds until the underlying cause has been resolved.

SurgiClose Silicone and Shield products contain silicone and are not suitable for patients with silicone sensitivity.
SurgiBind is not indicated for procedures requiring load-bearing support, such as hernia repair, for intraperitoneal organ contact, or where a bridging effect is needed.
SurgiBind Tendon Protect is not indicated to replace or repair the damaged tendon or to reinforce the strength of any tendon repair.
Always follow the product’s labeling for indications and contraindications.

A surgeon must always rely on their professional clinical judgment when deciding whether to use a specific product for a patient. Kerecis does not dispense medical advice and strongly recommends that surgeons be adequately trained in the use of its products before employing them in surgical procedures. The information provided on this website is intended to demonstrate the product offerings and should not replace the package insert, product label, or instructions for use. For regulatory and medical practice reasons, product availability may vary by market. Contact your Kerecis representative for further clarification.

For single patient use only; do not reuse, reprocess, or re-sterilize.
Discard any unused portions of the product.
Sterile only if the package is unopened and undamaged.
Do not use the product if the package seal has been broken, unintentionally opened, or if handling has caused damage or contamination.
Do not use after the expiration date printed on the product label or packaging.
Remove all non-viable and necrotic tissue prior to application of the product.
Remove exudate and control bleeding prior to product application.
Do not use in patients with known fish allergies.
The product is not designed, sold, or intended for use except as indicated.
No clinical trials have been conducted in pediatric, pregnant, or breastfeeding populations.

Need more information?

From the town of Ísafjörður in northwest Iceland, Kerecis develops, manufactures, and distributes patented fish-skin medical devices that support soft tissue regeneration in the body, with regulatory clearance in the United States, Europe, and beyond.

Shield – U.S. Product Details and Resources