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Sasmar Classic 118ml

by Sasmar Pharmaceuticals SPRL

Sasmar Classic 118ml (880854) is a general-body orifice lubricant (FDA Class II; FDA product code NUC, Lubricant, Personal) made by Sasmar Pharmaceuticals SPRL, cleared under FDA 510(k) K131084 on 13 Sep 2013 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 09337213008549), 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) K131084

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 Number09337213008549 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131084 Date13 Sep 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131084 decided 13 Sep 2013 Active
  • FDA GUDID UDI-DI 09337213008549 listed 3 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131084
  2. Listed FDA GUDID 09337213008549

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sasmar Classic
Generic name
General-body orifice lubricant, non-sterile
Model / Ref / Catalog
118ml, 880854
Primary DI / UDI-DI
09337213008549
510(k) Number
FDA product code
NUC
GMDN term
General-body orifice lubricant, non-sterile
Device class
Class II
Regulation number
884.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vaginal lubricantGeneral-body orifice lubricant, non-sterile

Cleared under the same submission (K131084)

and 8 more cleared under K131084

Similar devices

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

Other devices from Sasmar Pharmaceuticals SPRL

See all devices from Sasmar Pharmaceuticals SPRL →

Properties

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