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Phoenix Optimal 2X D-8012X10-236B

by Phoenix Orthodontics 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060772890181 UDI-DI Date17 Aug 2020ListedStatusListed 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  • Withdrawn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
Phoenix Optimal 2X
Generic Name
Orthodontic tube
Model / Ref / Catalog
D-8012X10-236B
Primary DI / UDI-DI
05060772890181
FDA Product Code
DZD
GMDN Term
Orthodontic tube
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No