ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
Device Facts
| Record ID | K961662 |
|---|---|
| Device Name | ADVANCED CARE HYDROPHILIC WOUND DRESSINGS |
| Applicant | Mariner Biomedical, Inc. |
| Product Code | KMF · General Hospital |
| Decision Date | Jun 13, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5090 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, lacerations, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.
Device Story
Hydrophilic polyurethane foam wound dressing; various thicknesses (100 mil to 0.05") and sizes (up to 25"x25"); sterile, individually packaged. Used in clinical or home settings for wound management; protects skin from irritation/maceration; manages exudate. Applied by healthcare providers or patients to surgical incisions, lacerations, trauma wounds, abrasions, burns, and ulcers.
Clinical Evidence
bench testing only
Technological Characteristics
Material: hydrophilic polyurethane foam. Form factor: sheets up to 25"x25", thickness 100 mil to 0.05". Sterilization: sterile.
Indications for Use
Indicated for local management of surgical incisions, lacerations, trauma wounds, abrasions, superficial burns, packed wounds, donor sites, and pressure, diabetic, or venous stasis ulcers. Protects skin from irritation/maceration and manages exudate.
Regulatory Classification
Identification
A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.
Predicate Devices
- Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing
Related Devices
- K971126 — HYDROCOLLOID WOUND DRESSINGS · Innovative Technologies , Ltd. · Jun 24, 1997
- K982778 — BIODERM FOAM WOUND DRESSING · Bioderm, Inc. · Oct 21, 1998
- K964016 — TIELLE HYDROPOLYMER FOAM DRESSING · Johnson & Johnson Medical, Inc. · Dec 31, 1996
- K971337 — EPITECH ISLAND DRESSINGS · Rynel, Ltd. Inc. · Jul 9, 1997
- K991920 — DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING · Dermaphylyx, Inc. · Aug 12, 1999
