MariGen - U.S. Product Details and Resources

Kerecis MariGen is intact fish skin for the management of chronic wounds such as diabetic wounds, pressure ulcers, vascular ulcers, and draining wounds commonly treated in hospital-based outpatient departments.

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 is classified as a medical device and consists of a full-thickness fish skin that has been processed using Kerecis’ proprietary EnviroIntact™ method.

Product information

Manufacturer Name: Kerecis Limited

Product Name (s): MariGen, MariGen Micro, MariGen Fenestrated, MariGen Expanse

Brand Name: MariGen

Generic Name: Fish-Skin Graft

Product Material: Sheet

HCPCS Code: Q4158

Q4158 HCPCS Code Listed Product Description: Kerecis omega3, per square centimeter

FDA Registration: K132343

FDA Clearance Date: October 23, 2013

FDA Clearance Type: 510(K)

First Marketing Date: October 23, 2013

Unit for Strength: SQ CM / Each

Number of Items per Package: 1

Number of Items per Alternate ID: 1

Units of Volume per Item for all Alt ID’s: 1

Product Code	MariGen Product Description – Size	Total Size cm2	Billable Units	HCPCS Code	UPC
50200S16B0D	MariGen – 16 mm, Circular, Diameter	2.01	2	Q4158	5694310960151
50200S00B0D	MariGen – 1.75 x 1.75 cm	3.06	4	Q4158	5694310960052
50200S01B0D	MariGen – 3 x 3.5 cm	10.50	11	Q4158	5694310962391
50200S02B0D	MariGen – 3 x 7 cm	21.00	21	Q4158	5694310962414
50200S05B0D	MariGen – 5 x 7 cm	35.00	35	Q4158	5694310960892
50200S04B0D	MariGen – 7 x 7 cm	49.00	49	Q4158	5694310960236
50200S03B0D	MariGen – 7 x 10 cm	70.00	70	Q4158	5694310962438
50200P00B0D	MariGen Micro – 4 sq cm	4.00	4	Q4158	5694310961578
50200P01B0D	MariGen Micro – 8 sq cm	8.00	8	Q4158	5694310961592
50200P02D0D	MariGen Mirco – 19 sq cm	19.00	19	Q4158	5694310961615
50200P04D0D	MariGen Micro – 38 sq cm	38.00	38	Q4158	5694310961653
50200F01B0D	MariGen Fenestrated – 3 x 3.5 cm	10.50	11	Q4158	5694310960175
50200F02B0D	MariGen Fenestrated – 3 x 7 cm	21.00	21	Q4158	5694310960199
50200F03B0D	MariGen Fenestrated – 7 x 10 cm	70.00	70	Q4158	5694310960212
50200N11B0D	MariGen Expanse – 7 x 8 cm	56.00	56	Q4158	5694310962216
50200N13B0D	MariGen Expanse – 8 x 10 cm	80.00	80	Q4158	5694310962230
50200N42B0D	MariGen Expanse – 2 x 2 cm	4.0	4	Q4158	5694310964463
50200N43B0D	MariGen Expanse – 3 x 3 cm	9.0	9	Q4158	5694310964487
50200N44B0D	MariGen Expanse – 4 x 4 cm	16.0	16	Q4158	5694310964500

Additional Information

• Study Links
• FDA Clearance Link
• Instructions for USE
• Contact Information

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.

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.

MariGen® – U.S. Product Details and Resources