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Conceive Plus 8x4g

by Sasmar Pharmaceuticals SPRL

Conceive Plus 8x4g (880845) is a vaginal lubricant (FDA Class II; FDA product code PEB, Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible) made by Sasmar Pharmaceuticals SPRL, cleared under FDA 510(k) K131355 on 7 Nov 2013 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 09337213008457), 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) K131355

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 Number09337213008457 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131355 Date7 Nov 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131355 decided 7 Nov 2013 Active
  • FDA GUDID UDI-DI 09337213008457 listed 3 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131355
  2. Listed FDA GUDID 09337213008457

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Conceive Plus
Generic name
Vaginal lubricant
Model / Ref / Catalog
8x4g, 880845
Primary DI / UDI-DI
09337213008457
510(k) Number
FDA product code
PEB
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 (K131355)

Similar devices

Other devices filed under FDA product code PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible).

Other devices from Sasmar Pharmaceuticals SPRL

See all devices from Sasmar Pharmaceuticals SPRL →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)