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ASSIST Silver

FDA UDI

Class U (US FDA UDI)

by Milliken Healthcare Pdts, Llc

Identity

Trade Name
ASSIST Silver FDA UDI
Generic Name
Wound-nonadherent dressing, permeable, antimicrobial FDA UDI
Device Name
ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST 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. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound." Dressing is perforated to allow passage of thick exudate. FDA UDI
Model / Reference
Perforated 6"x6" FDA UDI
Description
ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST 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. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound." Dressing is perforated to allow passage of thick exudate. FDA UDI

Identifiers

Catalog Number
3000119463 FDA UDI
Primary DI / UDI-DI
00015961681519 FDA UDI
510(k) Number
K103141 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Wound-nonadherent dressing, permeable, 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

Category: Wound-nonadherent dressing, permeable, antimicrobial

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

Similar devices

Also classified as Wound-nonadherent dressing, permeable, antimicrobial.

Cleared under the same submission

K103141 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 b751c68c-9ba6-4679-833d-ee09d4ac8f48 37 fields · synced May 30, 2026