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Ion Tomosynthesis Board 380456

by Intuitive Surgical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886874124871 UDI-DI Date11 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ion Tomosynthesis Board
Generic Name
Radiological image marker, noninvasive, reusable
Model / Reference
380456
Primary DI / UDI-DI
00886874124871
FDA Product Code
EOQ
GMDN Term
Radiological image marker, noninvasive, reusable
Device Class
Class II
Regulation Number
874.4680
GUDID distribution status
In Commercial Distribution

Other devices from Intuitive Surgical, Inc.

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Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • 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
  • Expiration Date: No