FDA.reportPublic FDA data

TRITEC

Primary DI
00015961477969
Brand
TRITEC
Company
MILLIKEN HEALTHCARE PDTS, LLC
Model
"4""x48"""
Catalog number
3000020051
Device description
"TRITEC is a polyester/nylon wound contact layer. TRITEC 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 dressing is white and the nylon side (side placed away from the wound) is printed with navy. The print is a circle logo with""Milliken"" above and ""TRITEC"" 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. "
Published
2021-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015961477966PackageGS110In Commercial Distribution
20015961477963PackageGS110In Commercial Distribution
00015961477969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001596147796610015961477966
2001596147796320015961477963
00015961477969000159614779690159614779690015961477969

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area192Square inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
18004326686HealthcareCustomerService@Milliken.com

Regulatory Flags#

DUNS number
963905539
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015961687078AGILE"4""x4"""30001172222021-02-04
00015961687085AGILE"2""x2"""30001199912021-02-04
00015961687092AGILE"Pre-cut 4""x4"""30001199922021-02-04
00015961687108AGILE"4""x10"""30001199932021-02-04
00015961293026ULTRA"4""x5"""30000068402021-01-06
00015961477952TRITEC"4""x5"""30000200402021-02-01
00015961649717ULTRA"8""x20"""30001122212021-01-06
00015961650041TRITEC"Pre-Cut 4""x5"""30001128162021-02-01
00015961669197ULTRA Border "3""x3"""30001168772021-01-06
00015961669203ULTRA Border "4""x10"""30001168802021-01-06
00015961669210ULTRA Border "4""x4"""30001168782021-01-06
00015961669227ULTRA Border "6""x6"""30001168792021-01-06
10015961687075AGILE4"x4"30001172222021-02-04
10015961687082AGILE2"x2"30001199912021-02-04
10015961687099AGILEPre-cut 4"x4"30001199922021-02-04
10015961687105AGILE4"x10"30001199932021-02-04
00015961293002ASSIST Absorbent"24""x36"""30000046222021-02-02
00015961293019ASSIST Silver Absorbent"24""x36"""30000069642021-02-02
00015961464358ASSIST Silver"4""x48"""30000511752021-02-02
00015961668640ASSIST Silver AbsorbentVest30001170072021-02-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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