Identity
- Trade Name
- Penile Adjustable Loop FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- Adjustable penile constriction band that can be used with or without a vacuum erection device. FDA UDI
- Model / Reference
- PAL-01 FDA UDI
- Description
- Adjustable penile constriction band that can be used with or without a vacuum erection device. FDA UDI
Identifiers
- Catalog Number
- PAL-01 FDA UDI
- Primary DI / UDI-DI
- 00850004857007 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
Yes
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
Category: Penile vacuum device
Penile Adjustable Loop by Reach Medical, Inc. — 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
- Reach Medical, Inc.
Sources (1)
- FDA UDI a7500a4e-8fe1-4d6d-854d-348323bdf165 35 fields · synced May 30, 2026