Overview
Per the manufacturer's brochure, intended for homologous use.
- Manufacturer
- Cellution Biologics, 4000 Northfield Way, Suite 400, Roswell, GA 30076
- Tissue type
- Human amnion - intermediate layer - chorion membrane allograft (dHAICM)
- Layers
- Three layers: amnion, intermediate layer, chorion
- Processing
- Sterile, minimally manipulated, dehydrated; intended for homologous use
- HCPCS Level II code
- Q4316 (as printed in the brochure)
- Regulatory status
- The brochure does not print an HCT/P 361 designation. TBD
- Applications listed (brochure)
- Non-infected acute and chronic wounds, with the brochure citing published literature for each listed condition
- Storage and shelf life
- Not yet published
- Clinical trials
- No randomized controlled trial yet; Fortify Medical expects one by January.
Specs & sizes
| Size |
|---|
| 14 mm disc |
| 18 mm disc |
| 2 x 2 cm |
| 2 x 3 cm |
| 2 x 4 cm |
| 2 x 6 cm |
| 3 x 3 cm |
| 3 x 5 cm |
| 4 x 4 cm |
| 4 x 6 cm |
| 4 x 7 cm |
| 4 x 8 cm |
| 5 x 5 cm |
| 6 x 8 cm |
| 6 x 12 cm |
| 7 x 7 cm |
| 10 x 10 cm |
| 10 x 20 cm |
| 20 x 20 cm |
Resources
Source: AmchoPlast brochure (CB/ACP/PHB V1 04/25, Cellution Biologics).
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