FDA.reportPublic FDA data

Kerecis® Omega3 BURN

Primary DI
05694310960410
Brand
Kerecis® Omega3 BURN
Company
KERECIS hf.
Model
10x25 Solid Burn
Catalog number
50202S22D0D
Device description
Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears).Double Pouchedhttps://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
Published
2021-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694310960410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694310960410056943109604105694310960410

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Width25Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7032878752info@kerecis.com

Regulatory Flags#

DUNS number
365732410
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05694310968560Kerecis SurgiClose® Silicone20 x 30 cm fish skin Fenestrated50214F61D0D2026-04-22
05694310968584Kerecis GraftGuide® Silicone20 x 30 cm fish skin Punched50213U61D0D2026-04-22
05694310966443Kerecis SurgiBind® Tendon Protect 3 x 5 cm 50242S70D0D2026-02-03
05694310966474Kerecis SurgiBind® Tendon Protect 6 x 9 cm 50242S71D0D2026-02-03
05694310966467Kerecis SurgiBind® Tendon Protect 3 x 5 cm 50242S70D0D2026-02-03
05694310966450Kerecis SurgiBind® Tendon Protect 6 x 9 cm 50242S71D0D2026-02-03
05694310967990Kerecis MariGen® 3 x 3.26 cm Fenestrated50200F72B0D2026-01-30
05694310968010Kerecis MariGen®4 x 5 cm Fenestrated50200F73B0D2026-01-30
05694310968034Kerecis MariGen®6 x 7 cm Fenestrated50200F74B0D2026-01-30
05694310968058Kerecis MariGen®5 x 11 cm Fenestrated50200F75B0D2026-01-30
05694310968072Kerecis MariGen®5 x 14 cm Fenestrated50200F76B0D2026-01-30
05694310968096Kerecis MariGen®5 x 14 cm Meshed 2:150200N76B0D2026-01-30
05694310968003Kerecis MariGen® 3 x 3.26 cm Fenestrated50200F72B0D2026-01-30
05694310968027Kerecis MariGen®4 x 5 cm Fenestrated50200F73B0D2026-01-30
05694310968041Kerecis MariGen®6 x 7 cm Fenestrated50200F74B0D2026-01-30
05694310968065Kerecis MariGen®5 x 11 cm Fenestrated50200F75B0D2026-01-30
05694310968089Kerecis MariGen®5 x 14 cm Fenestrated50200F76B0D2026-01-30
05694310968102Kerecis MariGen®5 x 14 cm Meshed 2:150200N76B0D2026-01-30
05694310965347Kerecis® MariGen®Expanse cm 6 x 6 / Meshed 3:150200O46B0D2025-08-29
05694310965361Kerecis® GraftGuide®300 sq cm Meshed 3:150202O23D0D2025-08-29

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