ULTRA Silver 3000051018

GUDID 20015961464376

ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ULTRA Silver dressings kill bacteria within the dressing and provides 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 polyester/ nylon wound contact layer coated with an ion-exchange silver, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with"Milliken" above and "ULTRA Silver" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.

MILLIKEN HEALTHCARE PDTS, LLC

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 20015961464376
• NIH Device Record Key: 7b10d65a-5e37-4139-8252-20c116aeec54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA Silver
• Version Model Number: 4"x5"
• Catalog Number: 3000051018
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015961464372 [Primary]
GS1	10015961464379 [Package]; Contains: 00015961464372; Package: Shelf box [10 Units]; In Commercial Distribution
GS1	20015961464376 [Package]; Contains: 10015961464379; Package: Shipper case [10 Units]; In Commercial Distribution

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: 2021-01-14
• Device Publish Date: 2021-01-06

On-Brand Devices [ULTRA Silver ]

• 20015961649704: ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for managem
• 20015961464376: ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for managem