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AccuPlan System ZB-KP100

by Medcad

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 Number00810007632223 UDI-DI Date2 Nov 2023ListedStatusListed 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  • Withdrawn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
AccuPlan System
Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog
ZB-KP100
Primary DI / UDI-DI
00810007632223
FDA product code
JEY, DZJ, LLZ
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class II
Regulation number
872.4760, 872.4120, 892.2050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Craniofacial fixation plate, non-bioabsorbable, non-customizedDental milling system, CAD/CAM, laboratoryCustom-made organ/bone anatomy model/surgical guide kit

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number

Other properties (9)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No
  • Manufacturing date: No