361 Allografts

National Supplier of HCT/P's

As a trusted and leading national supplier of Human, Cellular and Tissue Products HCT/P’s, MD Biologix is proud to offer a comprehensive range of high-quality, innovative solutions.

Single Layer Allografts
Dual Layer Allografts
Triple Layer Allografts
Full-Thickness Allografts

Section 361 HCT/Ps

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 allografts

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 Allograft Portfolio

HCPCS	DESCRIPTION	REF	SIZE	UNITS
Q4239	Amnio-Maxx® Dual Layer Amnion Allograft	AMN-22	2cm x 2cm	4
Q4239	Amnio-Maxx® Dual Layer Amnion Allograft	AMN-23	2cm x 3cm	6
Q4239	Amnio-Maxx® Dual Layer Amnion Allograft	AMN-24	2cm x 4cm	8
Q4239	Amnio-Maxx® Dual Layer Amnion Allograft	AMN-44	4cm x 4cm	16
Q4239	Amnio-Maxx® Dual Layer Amnion Allograft	AMN-48	4cm x 8cm	32

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 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

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-24224	4cm x 4cm	16
Q4348	Sentry SL Matrix	SEN-24248	4cm x 8cm	32

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