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Premier Jackson Improved Extra Long Tracheostomy Tube 1034967

by Premier Dental Products Company

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 Number00348783011067 UDI-DI Date9 Jun 2026ListedStatusListed 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  • Withdrawn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
Premier Jackson Improved Extra Long Tracheostomy Tube
Generic Name
Surgical instrument/endoscope cleaning utensil, reusable
Model / Reference
1034967
Primary DI / UDI-DI
00348783011067
FDA Product Code
BTO
GMDN Term
Surgical instrument/endoscope cleaning utensil, reusable
Device Class
Class II
Regulation Number
868.5800
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

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

Other properties (10)

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