CMS Confirms Coverage of Kerecis Fish-Skin Products by Medicare
November 14, 2024
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Kerecis GraftGuide is intact fish-skin especially developed for the management of burn wounds.
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 classifies as a medical device and consist of a full thickness fish-skin that has been processed using Kerecis’ proprietary EnviroIntact™ method. The product is not subject to the May 31, 2021, FDA 351 regulation.
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | hagustsson | 28/02/2024 15:29 | 50202S03D0D | GraftGuide 7×10 cm | 7 x 10 cm | 70 |
| 2 | avista | 27/02/2024 22:01 | hagustsson | 28/02/2024 15:29 | 50202S21D0D | GraftGuide 7×20 cm | 7 x 20 cm | 140 |
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | avista | 27/02/2024 22:44 | 50202P32D0D | GraftGuide Micro 114 sq cm | 114 cm2 | up to 114 |
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | avista | 27/02/2024 22:49 | 50202N33D0D | GraftGuide Mano Medium 147 sq cm Dorsum L / Palmar R | Medium 147 cm2 | 147 |
| 2 | avista | 27/02/2024 22:50 | avista | 27/02/2024 22:50 | 50202N34D0D | GraftGuide Mano Medium 147 sq cm Dorsum R / Palmar L | Medium 147 cm2 | 147 |
| 3 | avista | 27/02/2024 22:51 | hagustsson | 28/02/2024 15:31 | 50202N35D0D | GraftGuide Mano Large 196 sq cm Dorsum L / Palmar R | Large 196 cm2 | 196 |
| 4 | avista | 27/02/2024 22:51 | hagustsson | 28/02/2024 15:31 | 50202N36D0D | GraftGuide Mano Large 196 sq cm Dorsum R / Palmar L | Large 196cm2 | 196 |
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | SKU | Product Description | Product Sizing | Total Units |
|---|---|---|---|---|---|---|---|---|
| 1 | avista | 27/02/2024 22:00 | avista | 27/02/2024 22:54 | 50202N03D0D | GraftGuide 7×10 cm meshed 2:1 | 7 x 10 cm meshed 2:1 | up to 126 |
| 2 | avista | 27/02/2024 22:50 | avista | 27/02/2024 22:55 | 50202N21D0D | GraftGuide 7×20 cm meshed 2:1 | 7 x 20 cm meshed 2:1 | up to 252 |
| 3 | avista | 27/02/2024 22:51 | avista | 27/02/2024 22:56 | 50202N24D0D | GraftGuide 250 sq cm meshed 2:1 | 250 cm2 meshed 2:1 | up to 450 |
| 4 | avista | 27/02/2024 22:51 | avista | 27/02/2024 22:56 | 50202N23D0D | GraftGuide 300 sq cm meshed 2:1 | 300 cm2 meshed 2:1 | up to 540 |
The product derives from a from a fish source and should not be used in patients with a known allergy to fish or sensitivity. 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 make sure to check with your local health care professional and read the actual printed package information prior to use. Information on this website might not be current and might not be an accurate reflection of 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 on directly or by linking to third-party websites, are provided for informational purposes only. Information on this website should not be considered as a substitute for advice from a healthcare professional.
Consult with a physician or other healthcare professional regarding any medical or health related diagnosis or treatment options.
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular 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 are intended to demonstrate the Kerecis product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Kerecis product.
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