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Xaciato 1048228

by Organon, Inc.

Xaciato 1048228 is a vaginal applicator (FDA Class I; FDA product code HGD, Applicator, Vaginal) made by Organon, Inc., listed in FDA GUDID since 13 Sep 2024 (UDI-DI 10378206189018), 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 Number10378206189018 UDI-DI Date13 Sep 2024ListedStatusListed 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  • Withdrawn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
Xaciato
Generic name
Vaginal applicator, single-use
Model / reference
1048228
Primary DI / UDI-DI
10378206189018
FDA product code
HGD
GMDN term
Vaginal applicator, single-use
Device class
Class I
Regulation number
884.4520
GUDID distribution status
In Commercial Distribution
Size
Weight — 5 Gram

Related devices

Category: Vaginal applicator, single-use

Other devices from Organon, Inc.

See all devices from Organon, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Combination product
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (7, all answered No)