Section 361
CAMPs
National Supplier of CAMPs
As a trusted and leading national supplier of Cellular, Acellular and Matrix-like Products, MD Biologix is proud to offer a comprehensive range of high-quality, innovative solutions.
Section 361 CAMPs
TRG Letter - FDA CBER Division
As part of our strict compliance policy, all products are required to obtain their TRG letter from the CBER division of the Food & Drug Administration prior to approval for distribution by MD Biologix.
Section 361 regulated CAMPs
All of MD Biologix’ section 361 regulated products satisfy the requirement for minimal manipulation and are used in a manner consistent with homologous use when applied as a wound covering or barrier.
Our CAMPs Portfolio
AmchoPlast - (Q4316)
AmchoPlast is a cutting-edge, sterile, minimally manipulated, dehydrated allograft designed to support homologous use in clinical applications. It is meticulously derived from human placental membranes, specifically the amnion, intermediate layer, and chorion, obtained from healthy, consenting donors. The allograft incorporates a basement membrane and a stromal matrix collagen layer, providing structural integrity and biological compatibility for therapeutic purposes
| HCPCS | DESCRIPTION | SIZE | UNITS |
|---|---|---|---|
| Q4316 | Amchoplast: Amnion Intermediate Layer Chorion Membrane Allograft | 1cm x 1cm | 1 |
| Q4316 | Amchoplast: Amnion Intermediate Layer Chorion Membrane Allograft | 2cm x 2cm | 4 |
| Q4316 | Amchoplast: Amnion Intermediate Layer Chorion Membrane Allograft | 2cm x 3cm | 6 |
| Q4316 | Amchoplast: Amnion Intermediate Layer Chorion Membrane Allograft | 2cm x 4cm | 8 |
| Q4316 | Amchoplast: Amnion Intermediate Layer Chorion Membrane Allograft | 4cm x 4cm | 16 |
| Q4316 | Amchoplast: Amnion Intermediate Layer Chorion Membrane Allograft | 4cm x 8cm | 32 |
Palingen Membrane - (Q4173)
PalinGen Membrane is a sterile allograft in the form of a tissue which acts as a scaffolding in partial and full-thickness acute and chronic wounds. The graft remains in the wound and is surgically anchored based on the clinician’s choice of fixation including staples or sutures when medically necessary.
| HCPCS | DESCRIPTION | REF | SIZE | UNITS |
|---|---|---|---|---|
| Q4173 | Palingen Membrane | PM-02 | 2cm x 2cm | 4 |
| Q4173 | Palingen Membrane | PM-03 | 2cm x 3cm | 6 |
| Q4173 | Palingen Membrane | PM-04 | 2cm x 4cm | 8 |
| Q4173 | Palingen Membrane | PM-04 | 4cm x 4cm | 16 |
| Q4173 | Palingen Membrane | PM-08 | 4cm x 8cm | 32 |
Sentry (Q4348)
- Single-layer amnion
- Flexible, easily manipulated
| HCPCS | DESCRIPTION | REF | SIZE | UNITS |
|---|---|---|---|---|
| Q4348 | Sentry SL Matrix | SEN-24222 | 2cm x 2cm | 4 |
| Q4348 | Sentry SL Matrix | SEN-24224 | 2cm x 4cm | 8 |
| Q4348 | Sentry SL Matrix | SEN-24244 | 4cm x 4cm | 16 |
| Q4348 | Sentry SL Matrix | SEN-24248 | 4cm x 8cm | 32 |
Derm-Maxx (Q4238)
- Human Dermis Allograft
- Sterile, Room Temperature
- Available in Fenestrated and Non-Fenestrated Matrices
Derm-Maxx® Dermal Matrix is an acellular human dermis graft sterilized using the Tutoplast® Tissue Sterilization Process. This proprietary process retains the three dimensional intertwined multidirectional fibers and mechanical properties of the native tissue. Derm-Maxx® Dermal Matrix provides a natural scaffold to support the body’s regenerative processes.* Available in both fenestrated and non-fenestrated formats.
| HCPCS | DESCRIPTION | REF | SIZE | UNITS |
|---|---|---|---|---|
| Q4238 | Derm-Maxx® Fenestrated Dermal Matrix | MDRMF-11 | 1cm x 1cm | 1 |
| Q4238 | Derm-Maxx® Fenestrated Dermal Matrix | MDRMF-22 | 2cm x 2cm | 4 |
| Q4238 | Derm-Maxx® Fenestrated Dermal Matrix | MDRMF-24 | 2cm x 4cm | 8 |
| Q4238 | Derm-Maxx® Fenestrated Dermal Matrix | MDRMF-44 | 4cm x 4cm | 16 |
| Q4238 | Derm-Maxx® Fenestrated Dermal Matrix | MDRMF-48 | 4cm x 8cm | 32 |
Activate Matrix (Q4301)
Activate™ is a full-thickness placental allograft, consisting of an amnion, chorion, and the intermediate spongy layer.
| HCPCS | DESCRIPTION | REF | SIZE | UNITS |
|---|---|---|---|---|
| Q4301 | Activate Matrix | ACT-27222 | 2cm x 2cm | 4 |
| Q4301 | Activate Matrix | ACT-27224 | 2cm x 4cm | 8 |
| Q4301 | Activate Matrix | ACT-27244 | 4cm x 4cm | 16 |
| Q4301 | Activate Matrix | ACT-27248 | 4cm x 8cm | 32 |
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