Identity
- Trade Name
- Vacurect FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- Vacurect vacuum erection device with 10 tension systems, 4 oz personal lubricant, 4 oz flavored lubricant, 2 oz service oil, travel bag, user's guide, and lifetime warranty. FDA UDI
- Model / Reference
- Deluxe 1002 FDA UDI
- Description
- Vacurect vacuum erection device with 10 tension systems, 4 oz personal lubricant, 4 oz flavored lubricant, 2 oz service oil, travel bag, user's guide, and lifetime warranty. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861753000217 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Penile vacuum device
Vacurect by Mainspring Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Mainspring Medical Llc
Sources (1)
- FDA UDI baa32541-cff9-4e06-afc5-6670f0c1fdd6 33 fields · synced May 30, 2026