TRITEC Silver
Basic Information
- Brand Name
- TRITEC Silver
- Primary DI
- 00015961292975
- Version / Model
- Strip 1x24
- Catalog Number
- 3000004574
- Company Name
- MILLIKEN HEALTHCARE PDTS, LLC
- Labeler DUNS
- 963905539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-01
- Public Version
- 1
- Public Version Date
- 2021-02-09
- Public Version Status
- New
- Public Device Record Key
- 06c83bc3-da7a-42b5-955e-938ceb96cc13
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48124 | Exudate-absorbent dressing, non-gel, antimicrobial | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10015961292972 | GS1 | Shelf box | 5 | In Commercial Distribution | |
| Primary | 00015961292975 | GS1 | ||||
| Package | 20015961292979 | GS1 | Inner Shipper | 10 | In Commercial Distribution | |
| Package | 30015961292976 | GS1 | Outer shipper | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 18004326686
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051445 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 24 | Square inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 131 Degrees Fahrenheit