TRITEC

Basic Information

• Brand Name: TRITEC
• Primary DI: 00015961477952
• Version / Model: 4"x5"
• Catalog Number: 3000020040
• Company Name: MILLIKEN HEALTHCARE PDTS, LLC
• Labeler DUNS: 963905539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-01
• Public Version: 2
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: cad0668c-e681-44c2-9919-a0e03922010a

Device Description

TRITEC is a polyester/nylon wound contact layer. TRITEC is indicated for the management of acute and chronic wounds: partial-thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressing is white and the nylon side (side placed away from the wound) is printed with navy. The print is a circle logo with "Milliken" above and "TRITEC" printed inside. The dressing is also printed with navy "this side away from wound," as well as a light blue repeating set of symbols of an arrow, heart, and shield.

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: Yes
• 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
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44970	Exudate-absorbent dressing, non-gel, non-antimicrobial	A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10015961477959	GS1	Shelf box	10	In Commercial Distribution
Primary	00015961477952	GS1
Package	20015961477956	GS1	Inner shipper	10	In Commercial Distribution
Package	30015961477953	GS1	Outer shipper	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	20	Square inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 131 Degrees Fahrenheit