Encore 44017 UNB - 3 kits
by Encore, Inc.
Encore 44017 UNB - 3 kits (44017 - 3) is a Class II device made by Encore, Inc., listed in FDA GUDID since 18 Feb 2019 (UDI-DI 00850358007417), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850358007417 | Date18 Feb 2019 | StatusListed |
Official records
- AccessGUDID record 00850358007417
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Encore
- Generic name
- Penile vacuum device
- Model / Ref / Catalog
- 44017 UNB - 3 kits, 44017 - 3
- Primary DI / UDI-DI
- 00850358007417
- 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).
- DACOMED NEGATIVE PRESSURE ERECTION DEVICE by Dacomed Corp.
- RELIANT by Walling Medical Equipment Co.
- REVIVE SYSTEM by Revive Systems Corp.
- MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING by Nanma Mfg Co., Ltd.
- VACUUM ERECTION DEVICE (VED) by MISSION PHARMACAL COMPANY
- ERCO-RIBBON -C by Ercons, Inc.
- FIRM MASTER by Bak Medical Products
- POS-T-VAC (AVP-1000) by Pos-T-Vac LLC
- VET (VACUUM ERECTION TECHNOLOGY) by Vetco, Inc.
- NANMA ADJUSTABLE CONSTRICTION RING by Nanma Mfg Co., Ltd.