DIALFIX PLUS 3

Basic Information

• Brand Name: DIALFIX PLUS 3
• Primary DI: 08800125000075
• Version / Model: 01
• Company Name: DFIX
• Labeler DUNS: 695689958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-28
• Public Version: 1
• Public Version Date: 2023-02-06
• Public Version Status: New
• Public Device Record Key: fd15d9dd-eb0c-4ca2-b018-53b83da33d2f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKY	System, Skin Closure	General, Plastic Surgery	878.4320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33873	Skin-closing tension device	A sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical excision of a skin defect, or for the implantation of a prosthesis to provide additional skin for coverage; it may additionally be used for offloading sutures in closed wounds. It is typically available as automatic self-closing skin hooks, or a tension line inserted through skin hooks at the wound margins for constant or adjustable tension application. It may be used as an alternative to skin grafting. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800125000075	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Wound size less than 5cm