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ASSIST Silver Absorbent

FDA UDI

Class U (US FDA UDI)

by Milliken Healthcare Pdts, Llc

Identity

Trade Name
ASSIST Silver Absorbent FDA UDI
Generic Name
Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
Device Name
ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver Absorbent is indicated for management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphedema, dermatological wounds, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ASSIST Silver Absorbent dressings provide an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer coated with an ion-exchange silver, two layers of absorptive non-woven, and a grey occlusive outer layer. The film outer layer (side placed away from the wound) is grey and embossed. The embossing is a circle logo with "ASSIST Silver" printed inside. The logo has "This side away from wound," embossed above and below. FDA UDI
Model / Reference
Extremity 26"x26" FDA UDI
Description
ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver Absorbent is indicated for management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphedema, dermatological wounds, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ASSIST Silver Absorbent dressings provide an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer coated with an ion-exchange silver, two layers of absorptive non-woven, and a grey occlusive outer layer. The film outer layer (side placed away from the wound) is grey and embossed. The embossing is a circle logo with "ASSIST Silver" printed inside. The logo has "This side away from wound," embossed above and below. FDA UDI

Identifiers

Catalog Number
3000117008 FDA UDI
Primary DI / UDI-DI
00015961668633 FDA UDI
510(k) Number
K083659 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Wound-nonadherent dressing, absorbent, 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, absorbent, antimicrobial

ASSIST Silver Absorbent 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, absorbent, antimicrobial.

Cleared under the same submission

K083659 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 bb2280ed-c09a-4daa-bdc0-93f77b574da0 37 fields · synced May 31, 2026