Identity
- Trade Name
- Encore FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Model / Reference
- SILICONE RING #6 FDA UDI
Identifiers
- Catalog Number
- 44003-6-001 FDA UDI
- Primary DI / UDI-DI
- 00850358007233 FDA UDI
- FDA Product Code
- LKY FDA UDI
- GMDN Term
- Penile vacuum device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Penile vacuum device
Encore by Encore, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Penile vacuum device.
- Timm Medical — Pos-T-Vac LLC
- Loading Cone — AUGUSTA MEDICAL SYSTEMS, L.L.C. · Class II
- Elite Custom Plus — AUGUSTA MEDICAL SYSTEMS, L.L.C. · Class II
- PERFORMANCE — Blush Novelties · Class II
- MAPTAG — MAPTAG (QINGDAO) MEDICAL TECHNOLOGY CO., LTD. · Class II
- SureEase Comfort 2 — AUGUSTA MEDICAL SYSTEMS, L.L.C. · Class II
- SureEase Comfort 1 — AUGUSTA MEDICAL SYSTEMS, L.L.C. · Class II
- Gesiva Medical — GESIVA MEDICAL LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Encore, Inc.
Sources (1)
- FDA UDI 4ab6392b-26d5-4e78-aaca-9c1294863a31 34 fields · synced May 30, 2026