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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 19 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 19 Oct 2026. What this means

Regulatory status

as of registry sync 19 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00021292014766 UDI-DI Date22 Sep 2021ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 19 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  • Withdrawn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 5 bevel Pen Needle 31G/6mm - 100ct box, S6H01C31-100V
Primary DI / UDI-DI
00021292014766
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
Needle Gauge — 31 Gauge
Length — 0.25 Inch

Related devices

Cleared under the same submission (K180720)

Show all (12)

Other devices from Trividia Health, Inc.

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Properties

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

Other properties (8)

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