Cutimed®

Basic Information

• Brand Name: Cutimed®
• Primary DI: 04042809433760
• Version / Model: 73227-00
• Catalog Number: 73227-00
• Company Name: BSN medical GmbH
• Labeler DUNS: 342651662
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 2
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: f9a355eb-f8da-4a2c-ac20-3b7cb61f3e33

Device Description

CUTIMED EPIONA STERILE 5.1X5.1CM 10 USA 2"X2"

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: No
• 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	Wound dressing with animal-derived material(s)	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
Package	04042809433784	GS1		5	In Commercial Distribution
Primary	04042809433760	GS1
Unit of Use	04042809668551	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	5.1	Centimeter
Length	5.1	Centimeter