Burlington
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
16- Orthopaedic Surgery
- 16
How a vendor review usually runs
An orthopedic practice or surgery center onboarding a new biologics supplier typically wants three things up front: proof the account will be tied to a verifiable NPI, a certificate of analysis for the lot in question, and a plain description of how the product was processed and tested before release. Precision Biologics provides all three as part of account setup rather than as a special request.
Logistics for shipments into the region
Cryopreserved Wharton's jelly formats are packed on dry ice in validated containers for overnight delivery and need to move into -80 degree Celsius storage soon after arrival - worth mapping out in advance for a surgery center that schedules procedures on specific days rather than keeping staff on-site daily. Lyophilized formats skip the cold chain and are handled according to the insert that ships with the lot.
- Overnight dry-ice shipment for cryopreserved formats
- -80C storage on arrival
- Shelf-stable handling for lyophilized formats per product insert
- Lot-level tracking on the clinic side
Documentation and regulatory verification
Precision Biologics does not make determinations about whether a specific intended use satisfies the minimal manipulation and homologous use criteria under 21 CFR 1271.10 - that is a judgment for the practice's medical director and its own counsel, informed by the documentation we provide. Vermont practices should also confirm licensure and scope questions directly with the Vermont Board of Medicine.
Setting up an account
Accounts open once an NPI is verified against the NPPES registry. Physicians are welcome to request a peer-level call with our team to review lot documentation, traceability, and ordering logistics before committing to a first order; these calls are about process and paperwork, not clinical advice. Pricing is available to verified accounts only.
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 you ship cryopreserved products to Vermont, or only shelf-stable formats?+
Both. Cryopreserved formats ship overnight on dry ice in validated containers; lyophilized formats are shelf-stable and ship without that handling.
What documentation should we request before our first order?+
A certificate of analysis for the specific lot, a donor eligibility summary, and a lot release record are the standard set; all are available to verified accounts.
Who decides whether a product fits our intended use under the HCT/P regulations?+
That determination sits with your practice and its own regulatory counsel. We provide documentation to support that review but do not advise on clinical use.