Encore Erect Pro Manual
by Encore, Inc.
Encore Erect Pro Manual (4035) is a Class II device made by Encore, Inc., listed in FDA GUDID since 12 Nov 2016 (UDI-DI 00850358007127), 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 | Number00850358007127 | Date12 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 00850358007127
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Encore
- Generic name
- Penile vacuum device
- Model / Ref / Catalog
- Erect Pro Manual, 4035
- Primary DI / UDI-DI
- 00850358007127
- FDA product code
- LKY
- GMDN term
- Penile vacuum device
- Device class
- Class II
- Regulation number
- 876.5020
- GUDID distribution status
- In Commercial Distribution
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