Providence
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
111- Orthopaedic Surgery
- 111
Shipping to Northeast orthopedic accounts
Cryopreserved Wharton's jelly products ship overnight on dry ice in validated containers, arriving ready for -80 degree Celsius storage. Orthopedic practices and surgery centers in Providence receive shipments on the same overnight schedule as verified accounts anywhere else in the country; there is no separate regional cold-chain process.
Lyophilized formats, including the freeze-dried Wharton's jelly product, are shelf-stable and are stored and reconstituted per the insert included with each lot, which can simplify logistics for a surgery center without dedicated ultra-low freezer capacity.
Vendor qualification for surgery centers
Ambulatory surgery centers generally qualify a tissue or biologics vendor through the same process used for any supply decision: confirming sourcing, requesting lot documentation, and restricting ordering to credentialed staff. Precision Biologics is built around that process rather than a direct sales approach.
Materials typically requested during qualification include a certificate of analysis, a donor eligibility summary, and an explanation of third-party sterility testing and lot release criteria.
NPI-verified accounts
Every order is tied to a National Provider Identifier confirmed against the NPPES registry before release. A multi-surgeon practice can register more than one ordering NPI under a single account, keeping each purchase record attached to the correct physician.
Checking your regulatory position
Whether a specific intended use for a Wharton's jelly or exosome product fits within 21 CFR 1271.10, or, for exosomes, section 351 biologic drug regulation, is a determination for the practice and its own counsel. We recommend confirming your position with the Rhode Island Board of Medical Licensure and Discipline and your own counsel before adding a new biologic line.
Precision Biologics supports that review with registration and licensure documentation, lot-level records, and physician-level calls about documentation rather than clinical guidance.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Do shipments to Providence take longer than shipments elsewhere in the Northeast?+
No. All verified accounts receive cryopreserved shipments overnight on dry ice in validated containers, regardless of region.
What should a surgery center request before its first order?+
Ask for the certificate of analysis, donor eligibility summary, and lot release record for the specific lot, along with Precision Biologics' registration and licensure documentation.
Can several surgeons at one practice order under a single account?+
Yes. Each ordering physician's NPI is attached to their own purchase records within a shared account.