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ZENTRUM i3 US 1V 8000-U1

by Mizuho Orthopedic Systems, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00842430108600 UDI-DI Date7 Dec 2018ListedStatusListed GUDID: not 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  • Withdrawn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
ZENTRUM i3 US 1V
Generic Name
Universal operating table, electromechanical
Model / Ref / Catalog
8000-U1
Primary DI / UDI-DI
00842430108600
FDA Product Code
GDC
GMDN Term
Universal operating table, electromechanical
Device Class
Class I
Regulation Number
878.4960
GUDID distribution status
Not in Commercial Distribution

Other devices from Mizuho Orthopedic Systems, Inc.

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Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No