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Loading Cone

by Augusta Medical Systems, L.L.C.

Loading Cone is a Class II device made by Augusta Medical Systems, L.L.C., listed in FDA GUDID since 17 Jul 2017 (UDI-DI 00852598007448), registry data as of 1 Jun 2026.

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

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852598007448 UDI-DI Date17 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Penile vacuum device
Model / reference
Loading Cone
Primary DI / UDI-DI
00852598007448
FDA product code
LKY
GMDN term
Penile vacuum device
Device class
Class II
Regulation number
876.5020
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LKY (Device, External Penile Rigidity).

Other devices from Augusta Medical Systems, LLC

See all devices from Augusta Medical Systems, LLC →

Properties

  • Over-the-counter
  • Premarket exempt
Other properties (13, all answered No)