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Epimed International, Inc 258-2205

by Epimed International, Inc United States GUDID

Product code GXI

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818788022943 UDI-DIDate21 Nov 2025ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1849-2020 FDA Class II initiated 21 Feb 2020
    • Terminated Z-1850-2020 FDA Class II initiated 21 Feb 2020

    Incorrect expiration date on introduction cannula packaging.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Epimed International, Inc
Generic Name
Percutaneous radio-frequency ablation probe cannula, single-use
Model / Ref / Catalog
258-2205
Primary DI / UDI-DI
00818788022943
510(k) Number
FDA Product Code
GXI
GMDN Term
Percutaneous radio-frequency ablation probe cannula, single-use
Device Class
Class II
Regulation Number
882.4725
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe
Size
Needle Gauge — 20 Gauge
Length — 5 Centimeter
Length — 5 Millimeter

Related devices

Cleared under the same submission (K041021)

Other devices from Epimed International, Inc

See all devices from Epimed International, Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (9)
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI bec899f2-105e-4120-9c8e-078146f718a6 37 fields · synced 23 Oct 2026