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Premier Online Exodontia Courses, Inc. Xtract-1

by Premier Online Exodontia Courses, 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 Number00990312105534 UDI-DI Date15 Apr 2026ListedStatusListed 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  • Withdrawn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
Premier Online Exodontia Courses, Inc.
Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Reference
XTRACT-1
Primary DI / UDI-DI
00990312105534
FDA Product Code
DZN
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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