TRITEC Silver

Primary DI
00015961292968
Brand
TRITEC Silver
Company
MILLIKEN HEALTHCARE PDTS, LLC
Model
"4x48"""
Catalog number
3000004575
Device description
"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. "
Published
2021-02-01
Public version status
New
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
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051445000MILLIKEN SILVER WOUND DRESSINGSMilliken Chemical2005-08-22FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015961292965PackageGS110In Commercial Distribution
20015961292962PackageGS110In Commercial Distribution
00015961292968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001596129296510015961292965
2001596129296220015961292962
00015961292968000159612929680159612929680015961292968

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, 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
Combination product
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
00015961477969TRITEC"4""x48"""30000200512021-02-01
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

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