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Portable Battery for Optune IBH9000

by Novocure (Israel) Ltd

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290107980197 UDI-DI Date20 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Portable Battery for Optune
Generic Name
Alternating electric field antimitotic cancer treatment system generator
Model / Ref / Catalog
IBH9000, 90019
Primary DI / UDI-DI
07290107980197
PMA Number
FDA Product Code
NZK
GMDN Term
Alternating electric field antimitotic cancer treatment system generator
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (P100034)

Show all (12)

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