ASSIST Silver
Basic Information
- Brand Name
- ASSIST Silver
- Primary DI
- 00015961681519
- Version / Model
- Perforated 6"x6"
- Catalog Number
- 3000119463
- Company Name
- MILLIKEN HEALTHCARE PDTS, LLC
- Labeler DUNS
- 963905539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-02
- Public Version
- 1
- Public Version Date
- 2021-02-10
- Public Version Status
- New
- Public Device Record Key
- b751c68c-9ba6-4679-833d-ee09d4ac8f48
Device Description
ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST 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. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound." Dressing is perforated to allow passage of thick exudate.
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 |
|---|---|---|---|---|
| 47203 | Wound-nonadherent dressing, permeable, antimicrobial | A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00015961681519 | GS1 | ||||
| Package | 10015961681516 | GS1 | Shelf box | 10 | In Commercial Distribution | |
| Package | 20015961681513 | GS1 | Inner case | 10 | In Commercial Distribution | |
| Package | 30015961681510 | GS1 | Outer case | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 18004326686
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103141 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 131 Degrees Fahrenheit