Identity
- Trade Name
- Dr. Joel Kaplan FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- 9" x 2.50" Cylinder FDA UDI
- Model / Reference
- 0201-250 FDA UDI
- Description
- 9" x 2.50" Cylinder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005747291 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.50 Inch FDA UDILength — 9 Inch FDA UDI
Category: Penile vacuum device
The Dr. Joel Kaplan is a Penile vacuum device, designed to facilitate the management of erectile dysfunction (ED) by creating selective penile tumescence and rigidity through an external application of a vacuum pump/sleeve and constriction ring.
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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
- Dr Joel Kaplan Inc
Sources (1)
- FDA UDI 2bb4e71b-bf09-4040-be86-82edcc368d57 35 fields · synced Jun 19, 2026