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THERA Plus 64410383

by Fourstar Group Inc.

THERA Plus 64410383 is a nasal breathing mouth tape (FDA Class I; FDA product code KGX, Tape And Bandage, Adhesive) made by Fourstar Group Inc., listed in FDA GUDID since 9 Jun 2026 (UDI-DI 00049696677547), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00049696677547 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
THERA Plus
Generic name
Nasal breathing mouth tape
Model / reference
64410383
Primary DI / UDI-DI
00049696677547
FDA product code
KGX
GMDN term
Nasal breathing mouth tape
Device class
Class I
Regulation number
880.5240
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KGX (Tape And Bandage, Adhesive).

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)