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Lelo Hex Lubricated Natural Rubber Latex Condom collection 3 pack

by Leloi AB 2 variants

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08852961033205 UDI-DI Date25 Jun 2026ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Basic male condom, Hevea-latex
Model / Reference
3 Pack
Primary DI / UDI-DI
08852961033205
FDA Product Code
HIS
GMDN Term
Basic male condom, Hevea-latex
Device Class
Class II
Regulation Number
884.5300
GUDID distribution status
Not in Commercial Distribution

Other devices from Leloi AB

See all devices from Leloi AB →

Properties

  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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