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ZENTRUM i3 BACK PAD W/ TEMPUR, 76mm 8000-7001-1

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 Number00842430101137 UDI-DI Date16 Aug 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  • Withdrawn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 BACK PAD W/ TEMPUR, 76mm
Generic Name
Operating table mattress, basic
Model / Ref / Catalog
8000-7001-1
Primary DI / UDI-DI
00842430101137
FDA Product Code
GDC
GMDN Term
Operating table mattress, basic
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
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No