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TRITEC Silver

FDA UDI

Class U (US FDA UDI)

by Milliken Healthcare Pdts, Llc

Identity

Trade Name
TRITEC Silver FDA UDI
Generic Name
Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Device Name
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. FDA UDI
Model / Reference
Pre-Cut 4"x5" FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
3000112331 FDA UDI
Primary DI / UDI-DI
00015961649687 FDA UDI
510(k) Number
K051445 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Area/Surface Area — 20 Square inch FDA UDI

Category: Exudate-absorbent dressing, non-gel, antimicrobial

TRITEC Silver by Milliken Healthcare Pdts, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.

Cleared under the same submission

K051445 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Milliken Healthcare Pdts, Llc

Sources (1)

  • FDA UDI df1f81fb-2329-4fe7-b9f9-d46d05ff1381 38 fields · synced May 30, 2026