Kerecis® Omega3 Wound

Basic Information

• Brand Name: Kerecis® Omega3 Wound
• Primary DI: 05694310960977
• Version / Model: 7x7 Particularized Wound
• Catalog Number: 50200P04D0D
• Company Name: KERECIS hf.
• Labeler DUNS: 365732410
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-01
• Public Version: 2
• Public Version Date: 2022-03-02
• Public Version Status: Update
• Public Device Record Key: e6d3690f-9f22-4429-ac24-d0f638ac0337
• Distribution End Date: 2022-02-24

Device Description

"Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.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	05694310960977	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	7	Centimeter
Length	7	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