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Encore AMERICAN PENILE TUBE

by Encore, Inc.

Encore AMERICAN PENILE TUBE (1118-001) is a Class II device made by Encore, Inc., listed in FDA GUDID since 25 Jul 2017 (UDI-DI 00850358007189), registry data as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850358007189 UDI-DI Date25 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  • Withdrawn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

Trade name
Encore
Generic name
Penile vacuum device
Model / Ref / Catalog
AMERICAN PENILE TUBE, 1118-001
Primary DI / UDI-DI
00850358007189
FDA product code
LKY
GMDN term
Penile vacuum device
Device class
Class II
Regulation number
876.5020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Penile vacuum device

Similar devices

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

Other devices from Encore, Inc.

See all devices from Encore, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)