Overview
Per the manufacturer's brochure, designed as a barrier or wound cover.
- Manufacturer
- Sequence LifeScience, Inc.
- Distributor
- Innovative Wound Consultants (IWC); the brochure lists the IWC website
- Tissue type
- Human placental-derived allograft: amniotic and chorionic membranes and intermediate (spongy) layer
- Processing
- Minimally manipulated, dehydrated; terminal sterilization by gamma irradiation (IFU), verified to a 10^-6 SAL (brochure)
- Regulatory status
- Described in the brochure as 361 HCT/P
- HCPCS Level II code
- Q4379, Amnio Defend Matrix, per square centimeter (as printed in the brochure)
- Intended use (brochure)
- Natural biologic wound covering or skin substitute for cutaneous wounds, applied by qualified health care professionals in a physician office, outpatient or inpatient setting
- Storage
- Foil packaging system: store in a clean, dry place at a controlled ambient temperature of 15-30 C (59-86 F). Do not freeze or refrigerate.
- Handling (IFU)
- Single patient use on a single occasion. Do not re-sterilize. Once the seal is broken the allograft must be transplanted or discarded; use within 8 hours of opening or hydration.
- Shelf life
- See the expiration date on the package label (no fixed shelf life is printed in the brochure or IFU)
- Clinical trials
- Fortify Medical reports randomized controlled trial(s) for this product. Trial data is not included in the manufacturer brochure.
Specs & sizes
| Size | SKU |
|---|---|
| 2 x 2 cm (4 sq cm) | AMN-27222 |
| 2 x 4 cm (8 sq cm) | AMN-27224 |
| 4 x 4 cm (16 sq cm) | AMN-27244 |
| 4 x 8 cm (32 sq cm) | AMN-27248 |
Resources
Source: Amnio Defend Placental-Derived Allograft brochure (MKT-008-AMD Rev. 00, Sequence LifeScience) and AmnioDefend FT Matrix Allograft Package Insert (TI-PI-013-AD, effective 08/13/2025).
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