Identity
- Trade Name
- Acanthus FDA UDI
- Generic Name
- Penis wearable urinal FDA UDI
- Device Name
- Acanthus Condom Catheter Medium-Large with 3ml Skin Adhesive FDA UDI
- Model / Reference
- ACC019796 FDA UDI
- Description
- Acanthus Condom Catheter Medium-Large with 3ml Skin Adhesive FDA UDI
Identifiers
- Catalog Number
- ACC019796, ACC01979615, ACC0197963, ACC0197966, ACC0197969 FDA UDI
- Primary DI / UDI-DI
- 00860005762606 FDA UDI
- FDA Product Code
- NNY FDA UDI
- GMDN Term
- Penis wearable urinal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 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
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 26.98 Millimeter FDA UDI
Category: Penis wearable urinal
Acanthus by Acanthus Medical Creations, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Penis wearable urinal.
- Wellead Male External Catheter — Well Lead Medical Co., Ltd · Class I
- Wellead Male External Catheter — Well Lead Medical Co., Ltd · Class I
- Men's Liberty — ARGENTUM MEDICAL, LLC · Class I
- Men's Liberty — ARGENTUM MEDICAL, LLC · Class I
- Wellead Male External Catheter — Well Lead Medical Co., Ltd · Class I
- Wellead Male External Catheter — Well Lead Medical Co., Ltd · Class I
- Wellead Male External Catheter — Well Lead Medical Co., Ltd · Class I
- Wellead Male External Catheter — Well Lead Medical Co., Ltd · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acanthus Medical Creations, Llc
Sources (1)
- FDA UDI 23639e15-0cdb-46b5-b595-e21ca6206012 36 fields · synced Jun 8, 2026