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TRUEplus

by Trividia Health, Inc. 37 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00021292009038 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Autoinjector needle
Model / Ref / Catalog
TRUEplus STERILE pen needles 29 GAUGE x 1/2", S5H01F29-100
Primary DI / UDI-DI
00021292009038
510(k) Number
FDA Product Code
FMI
GMDN Term
Autoinjector needle
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
Not in Commercial Distribution
Size
Length — 0.5 Inch
Needle Gauge — 29 Gauge

Related devices

Cleared under the same submission (K143437)

Other devices from Trividia Health, Inc.

See all devices from Trividia Health, Inc. →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No