Identity
- Trade Name
- Drionic TM FDA UDI
- Generic Name
- Hyperhidrosis iontophoresis system FDA UDI
- Device Name
- Drionic Underarm Applicator Modules FDA UDI
- Model / Reference
- Underarm Modules FDA UDI
- Description
- Drionic Underarm Applicator Modules FDA UDI
Identifiers
- Catalog Number
- DUAM FDA UDI
- Primary DI / UDI-DI
- 00017344000009 FDA UDI
- FDA Product Code
- EGJ FDA UDI
- GMDN Term
- Hyperhidrosis iontophoresis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5525 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
Yes
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
No
FDA UDI
Category: Hyperhidrosis iontophoresis system
Drionic TM by General Medical Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hyperhidrosis iontophoresis system.
- DAAVLIN — Hidrex GmbH · Class II
- Fischer — A.R. Hinkel Co., Inc. · Class II
- Phothera — Hidrex GmbH · Class II
- Fischer — A.R. Hinkel Co., Inc. · Class II
- HIDREX USA — Hidrex GmbH · Class II
- HIDREX USA — Hidrex GmbH · Class II
- The Fischer — Saalmann medical GmbH & Co. KG · Class II
- Drionic TM — General Medical Co. · 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 |
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Manufacturer
- Manufacturer
- General Medical Co.
Sources (1)
- FDA UDI 6d39558b-427d-44ca-9f48-a58d8e91e2d5 35 fields · synced May 30, 2026