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Product Type: Allogeneic matrix
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Osiris Therapeutics, Inc. | |
HCPCS : Q4133 (Medicare DME co-payment per billable unit min / max: $0.00 / $0.00)
Grafix is a cryopreserved placental membrane comprised of an extracellular matrix (ECM) rich in collagen, growth factors, fibroblasts, mesenchymal stem cells (MSCs), and epithelial cells native to the tissue.
INTENDED USE:Designed for application directly to acute and chronic wounds.
CLAIMED FEATURES: Flexible, conforming cover that adheres to complex anatomies. Processed from donated human placental tissue. Processed aseptically in a controlled clean room environment, following rigorous quality control testing per FDA regulations and the American Association of Tissue Banks (AATB) standards. Grafix PRIME is made of human amniotic membrane.
OPTIONS: Grafix PRIME Sizes - 16 mm (2 mm2), Billable Units 2.1.5x2 cm (3 cm2), Billable Units 3. 2x3 cm (6 cm2), Billable Units 6. 3x4 cm (12 cm2), Billable Units 12. 5x5 cm (25 cm2), Billable Units 25. XC 7.5x15 cm (113 cm2), Billable Units 113. HCPC Q4133
Wound Reference does not produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients.
Composition: Animal-derived
Composition: Human dermis with/without epidermis
Composition: Human placenta or umbilical cord
Composition: Viable (living) cells
Configuration: Fenestrated/ meshed
Configuration: Flowable
Configuration: Sheet
May apply on full-thickness wounds
May apply over exposed tendon/ bone/ muscle
May apply over infected tissue
Processing: Cryopreserved
Processing: Decellularized or irradiated
Processing: Dehydrated
Processing: Fresh (limited shelf life)
Processing: Hydrated
Processing: Minimally manipulated
Shelf life: Greater than 2 years
Storage: refrigeration needed
Storage: room temp
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The addition of Skin Substitutes or Cellular or Tissue Based Products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing, after at least a 30 day period of comprehensive conservative therapy. There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. • Human skin allografts are derived from donated human skin (cadavers) • Allogeneic matrices are derived from human tissue (fibroblasts or membrane) • Composite matrices are derived from human keratinocytes, fibroblasts and xenogeneic collagen • Acellular matrices are derived from xenogeneic collagen or tissue

For Medicare to cover this product, it needs to be ordered and applied by your clinician. A patient cannot purchase it directly from a Durable Medical Equipment (DME) store and receive reimbursement for it.

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