ASSIST Silver 3000119464

GUDID 10015961681509

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.

MILLIKEN HEALTHCARE PDTS, LLC

Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 10015961681509
• NIH Device Record Key: 8dfc79c1-6293-4f27-8b74-27189bbec89d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSIST Silver
• Version Model Number: Perforated 4"x48"
• Catalog Number: 3000119464
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015961681502 [Primary]
GS1	10015961681509 [Package]; Contains: 00015961681502; Package: Inner case [10 Units]; In Commercial Distribution
GS1	20015961681506 [Package]; Package: Outer case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103141

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: 2021-02-10
• Device Publish Date: 2021-02-02

On-Brand Devices [ASSIST Silver]

• 00015961681519: ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a mult
• 10015961681509: ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a mult
• 00015961681496: ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a mult
• 00015961464396: ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a mult
• 00015961464365: ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a mult
• 10015961464355: ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a mult