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. It is not subject to the May 31, 2021, FDA 351 regulation.

Kerecis Omega3 Marigen Expanse

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 Approval Date: October 23, 2013
  • FDA Approval 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

The product is derived from a fish source and should not be used in patients with a known allergy or sensitivity to fish.

Note that fish allergy is not the same as shellfish allergy.

The product and its variations are not available in all countries and may be known under different trade names. Products, product names, indications, and claims vary between jurisdictions. Contact your Kerecis representative if you have questions about the availability of Kerecis products in your area.

Always check with your local healthcare professional and read the printed package information before use. The information on this website may not be current and may not accurately reflect current product labeling.

The product and its variations are not available in all countries and may be known under different trade names. Products, product names, indications, and claims vary between jurisdictions. Contact your Kerecis representative if you have questions about the availability of Kerecis products in your area.

Always check with your local healthcare professional and read the printed package information before use. The information on this website may not be current and may not accurately reflect current product labeling.

This website is not intended to provide diagnosis, treatment, or medical advice. Products, services, information, and other content provided on this website, including information that may be provided directly or by linking to third-party websites, are provided for informational purposes only.

Information on this website should not be considered a substitute for a healthcare professional’s advice. Consult with a physician or other healthcare professional regarding any medical or health-related diagnosis or treatment options.

A Surgeon must always rely on their professional clinical judgment when deciding whether to use a particular product when treating a patient. Kerecis does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented on this website is intended to demonstrate the Kerecis product offerings. Before using any Kerecis product, a surgeon must always refer to the package insert, product label, and/or instructions for use.

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