TRITEC Silver 3000004574

GUDID 10015961292972

TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-exchange silver. TRITEC Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. TRITEC Silver 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 dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy and a light blue. The navy print is a circle logo with"Milliken" above and "TRITEC Silver" 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.

MILLIKEN HEALTHCARE PDTS, LLC

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 10015961292972
• NIH Device Record Key: 06c83bc3-da7a-42b5-955e-938ceb96cc13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRITEC Silver
• Version Model Number: Strip 1x24
• Catalog Number: 3000004574
• Company DUNS: 963905539
• Company Name: MILLIKEN HEALTHCARE PDTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com
• Phone: 18004326686
• Email: healthcarecustomerservice@milliken.com

Device Dimensions

• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch
• Area/Surface Area: 24 Square inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015961292975 [Primary]
GS1	10015961292972 [Package]; Contains: 00015961292975; Package: Shelf box [5 Units]; In Commercial Distribution
GS1	20015961292979 [Package]; Package: Inner Shipper [10 Units]; In Commercial Distribution
GS1	30015961292976 [Package]; Contains: 20015961292979; Package: Outer shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051445

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-09
• Device Publish Date: 2021-02-01

On-Brand Devices [TRITEC Silver]

• 10015961649684: TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
• 10015961292989: TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
• 10015961292972: TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
• 10015961292965: TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
• 10015961292958: TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
• 10015961292934: TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex