Duns Number:963905539
Device Description: TRITEC is a polyester/nylon wound contact layer. TRITEC is indicated for the management of 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.
Catalog Number
3000020040
Brand Name
TRITEC
Version/Model Number
4"x5"
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
cad0668c-e681-44c2-9919-a0e03922010a
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
February 01, 2021
Package DI Number
10015961477959
Quantity per Package
10
Contains DI Package
00015961477952
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf 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 |