Symvess Implant
NDC Package 83564-110-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Symvess (acellular tissue engineered vessel) implants is sYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. This formulation utilizes a implant delivery system. Marketed by Humacyte Global, Inc., this product is identified by NDC 83564-110 and is authorized under FDA application BLA125812.

Identification & Billing

NDC Package Code
83564-110-00
Package Description
1 BOX in 1 BAG / 1 IMPLANT in 1 BOX (83564-110-01)
Product Code
83564-110
11-Digit Billing Format
83564011000
RxNorm Crosswalk
  • RxCUI: 2700346 - acellular tissue engineered vessel-tyod Vascular Implant
  • RxCUI: 2700346 - acellular tissue engineered vessel-tyod 40 CM Drug Implant
  • RxCUI: 2700352 - Symvess Vascular Implant
  • RxCUI: 2700352 - acellular tissue engineered vessel-tyod 40 CM Drug Implant [Symvess]
  • RxCUI: 2700352 - Symvess (acellular tissue engineered vessel-tyod) Vascular Implant

Clinical Specifications

Proprietary Name
Symvess
Non-Proprietary Name
Acellular Tissue Engineered Vessel
Substance Name
Acellular Tissue Engineered Vessel
Dosage Form
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Administration Route
Intravascular - Administration within a vessel or vessels.
Active Ingredient(s)
ACELLULAR TISSUE ENGINEERED VESSEL 420 mm/1
Usage Information
SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

Regulatory & Marketing

Labeler Name
Humacyte Global, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125812
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-19-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83564-110-00 identifies a specific commercial package of 1 box in 1 bag / 1 implant in 1 box (83564-110-01) of Symvess, a human prescription drug labeled by Humacyte Global, Inc.. This implant is formulated for intravascular use and contains acellular tissue engineered vessel as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Humacyte Global, Inc. on December 19, 2024. The current certification is valid through December 31, 2026.

How is this Humacyte Global, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83564011000. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83564-110-00
11-Digit CMS (5-4-2)
83564-0110-00

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.