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Umbilical cord tissue allografts in this line are HCT/P 361 products from FDA-registered banks — collagen, hyaluronic acid, and extracellular matrix for homologous use. They are not approved stem-cell drugs.
Written for licensed providers. Reviewed by Joe Bradley, Founder & CEO. Content version 2026-09-18.
HCT/P 361 compliant umbilical cord tissue allografts from FDA-registered tissue banks. Full documentation and compliance support.
Umbilical cord tissue in this catalog is 361 HCT/P structural tissue from FDA-registered banks. Homologous use, minimal manipulation. It is not a stem-cell drug and it is not “FDA approved” in the BLA sense. Lot files stay with the chart.
Donated umbilical cord processed to preserve structural matrix. Claims should stay inside the IFU. “Stem cells inside” marketing is how 361 products get practices in trouble.
Every lot should be receivable against donor-screening paperwork. If receiving cannot find the packet, do not implant.
Follow the bank IFU. A distributor who cannot state storage range is not ready to be your vendor of record.
These SKUs are offered as 361 HCT/Ps. We do not position them as BLA/351 cellular drugs.
Required. Indication language on the chart should match labeled function.
No. This is donated tissue, not PRP.
IFU, lot, expiry, indication, and application site.
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