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Heb 7W9261JC3

by H. E. Butt Grocery Company

Heb 7W9261JC3 is a vaginal lubricant (FDA Class II; FDA product code NUC, Lubricant, Personal) made by H. E. Butt Grocery Company, cleared under FDA 510(k) K180923 on 9 Jul 2018 and listed in FDA GUDID since 2 Dec 2024 (UDI-DI 00041220706259), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K180923

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00041220706259 UDI-DI Date2 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180923 Date9 Jul 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180923 decided 9 Jul 2018 Active
  • FDA GUDID UDI-DI 00041220706259 listed 2 Dec 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180923
  2. Listed FDA GUDID 00041220706259

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Heb
Generic name
Vaginal lubricant
Model / reference
7W9261JC3
Description
Lubricant Jelly 4 oz. (113g)
Primary DI / UDI-DI
00041220706259
510(k) Number
FDA product code
NUC
GMDN term
Vaginal lubricant
Device class
Class II
Regulation number
884.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vaginal lubricant

Cleared under the same submission (K180923)

and 4 more cleared under K180923

Similar devices

Other devices filed under FDA product code NUC (Lubricant, Personal).

Other devices from H. E. Butt Grocery Company

See all devices from H. E. Butt Grocery Company →

Properties

  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)