TRITEC Silver 3000004573

GUDID 10015961292958

TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-exchange silver. TRITEC Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. TRITEC 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 and a light blue. The navy print is a circle logo with"Milliken" above and "TRITEC Silver" printed inside. The dressing is also printed with navy "this side away from wound," as well as a light blue repeating set of symbols of an arrow, heart, and shield.

MILLIKEN HEALTHCARE PDTS, LLC

Exudate-absorbent dressing, non-gel, antimicrobial
Primary Device ID10015961292958
NIH Device Record Key79fc97f8-a111-4fc3-ac84-1908c2f832f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRITEC Silver
Version Model Number6x6
Catalog Number3000004573
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

Device Dimensions

Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch
Area/Surface Area36 Square inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100015961292951 [Primary]
GS110015961292958 [Package]
Contains: 00015961292951
Package: Shelf box [10 Units]
In Commercial Distribution
GS120015961292955 [Package]
Package: Inner shipper [10 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 Date2021-02-09
Device Publish Date2021-02-01

On-Brand Devices [TRITEC Silver]

10015961649684TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
10015961292989TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
10015961292972TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
10015961292965TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
10015961292958TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex
10015961292934TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-ex

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