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Optune Pax Battery Charger ICH9100

by Novocure Inc GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290107987486 UDI-DIDate16 Feb 2026ListedStatusListed GUDID: 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  • Withdrawn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
Optune Pax Battery Charger
Generic Name
Alternating electric field antimitotic cancer treatment system generator
Model / Ref / Catalog
ICH9100, ICH9204US
Primary DI / UDI-DI
07290107987486
PMA Number
FDA Product Code
SHC
GMDN Term
Alternating electric field antimitotic cancer treatment system generator
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P250034)

Other devices from Novocure Inc

See all devices from Novocure Inc →

Properties

  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (11)

  • 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
  • Manufacturing Date: No