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symphonX™ Introducer

by Fortimedix Surgical B.V. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08719324463003 UDI-DIDate15 Feb 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
symphonX™
Generic Name
Laparoscopic multi-instrument access port, reusable
Model / Ref / Catalog
Introducer, 314-101
Primary DI / UDI-DI
08719324463003
FDA Product Code
OTJ
GMDN Term
Laparoscopic multi-instrument access port, reusable
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Fortimedix Surgical B.V.

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No