ASSIST Silver Absorbent 3000006964

GUDID 10015961293016

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.

MILLIKEN HEALTHCARE PDTS, LLC

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID10015961293016
NIH Device Record Key38b33892-ec05-458c-98ae-609c03c8fea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSIST Silver Absorbent
Version Model Number24"x36"
Catalog Number3000006964
Company DUNS963905539
Company NameMILLIKEN HEALTHCARE PDTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100015961293019 [Primary]
GS110015961293016 [Package]
Contains: 00015961293019
Package: Shipper case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

On-Brand Devices [ASSIST Silver Absorbent]

10015961668647ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
00015961668633ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
00015961668626ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
00015961664147ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
10015961293016ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi

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