Duns Number:963905539
Device Description: TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an 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.
Catalog Number
3000005211
Brand Name
TRITEC Silver
Version/Model Number
8x16
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051445,K051445
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
7bbe910c-f2aa-4653-8cbf-cc95255a49ed
Public Version Date
February 09, 2021
Public Version Number
1
DI Record Publish Date
February 01, 2021
Package DI Number
10015961292989
Quantity per Package
50
Contains DI Package
00015961292982
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| U | Unclassified | 5 |