Kerecis® Omega3 BURN

Basic Information

• Brand Name: Kerecis® Omega3 BURN
• Primary DI: 05694310960458
• Version / Model: 7x10 Meshed Burn
• Catalog Number: 50202M03D0D
• Company Name: KERECIS hf.
• Labeler DUNS: 365732410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-15
• Public Version: 1
• Public Version Date: 2021-02-23
• Public Version Status: New
• Public Device Record Key: 67df91fa-9685-4c0d-8f10-d2cc6717de97

Device Description

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	Dressing, Wound, Collagen	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Collagen wound matrix dressing	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05694310960458	GS1
Package	05694310960465	GS1	Box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	7	Centimeter
Width	10	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry