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Diva Biome Balancer Applicator 1

by Diva International Inc

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841445001388 UDI-DI Date6 Feb 2026ListedStatusListed GUDID: 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  • Withdrawn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
Diva Biome Balancer Applicator
Generic Name
Vaginal applicator, reusable
Model / Reference
1
Primary DI / UDI-DI
00841445001388
FDA Product Code
HGD
GMDN Term
Vaginal applicator, reusable
Device Class
Class I
Regulation Number
884.4520
GUDID distribution status
In Commercial Distribution

Other devices from Diva International Inc

See all devices from Diva International Inc →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (12)

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