Specifications
- Listed presentation
- 1 mL / 2 mL vials
- Account access
- Licensed clinics and physician-supervised practices; request account verification
- Purchase review
- Request current label, composition, lot records, and handling instructions
- Listed tissue weight, 1 mL
- 300 mg on the supplier’s 1 mL page; not extrapolated to 2 mL
Presentation and scope
The supplier describes a Wharton’s jelly formulation in separate 1 mL and 2 mL presentations. Compare the current label for each size; volume does not establish composition equivalence or an appropriate quantity for use.
Keep the product name, size, and revision of the supplied label together in the purchasing file. A catalog description helps identify an item; it does not replace the documentation for the lot being considered.
Source and supplier process
The supplier describes tissue donation by consenting mothers after full-term C-section delivery, with recovery by licensed personnel. Its process description includes donor medical and social history review and serology screening.
Processing is described by the supplier as following FDA regulations and AATB/AABB guidelines. These are supplier descriptions, not statements that Precision Biologics operates a tissue bank, holds accreditation, or has received product approval.
Lot review before receipt
The supplier describes unique lot identification, third-party sterility testing, and quarantine until testing and internal release criteria are complete. Ask which records apply to the product and lot in your order.
Request a certificate of analysis, the applicable donor eligibility summary, release status, expiration information, and the current insert. Record any unavailable document as an open item for your clinic’s purchasing reviewer.
Receiving and storage review
For cryopreserved products, the supplier describes slow-rate freezing, storage at -80°C, and overnight dry-ice shipping in validated containers. Confirm that the selected SKU uses that shipping configuration and follow its current insert at receipt.
Assign a receiving contact, check the vial and shipping records against the purchase order, and preserve the lot identifier in inventory. If labeling or handling records disagree, hold the item for a written supplier disposition before any release decision.
Intended use belongs in a separate review
For licensed clinic procurement. This is not a stem cell therapy. No clinical outcome is represented. The ordering physician and clinic counsel must review the current labeling, product classification, and intended use before any purchase or use decision. Account verification does not establish permission for a clinical application.
A tissue format, analytical panel, or account approval does not establish a permitted application. Route unresolved labeling and regulatory questions to clinic counsel rather than using a catalog description as a clinical protocol.
Frequently asked questions
What should our purchasing team request?+
Request the current label, lot-specific analysis, applicable donor eligibility summary, release record, expiration details, and handling instructions. Confirm document availability before ordering.
Does the listed format establish an intended use?+
No. Presentation and analytical specifications do not establish a permitted application. The physician and clinic counsel review intended use separately.
Can patients purchase this product?+
Accounts are for licensed clinics, physicians, and practices operating under physician supervision. Contact Precision Biologics for account verification.