Identity
- Trade Name
- ManaMed Inc FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- This Ultrasound Coupling Gel is to be used with our ManaSport+ product or any other Ultrasound devices or non-adhesive electrodes. This allows the wave pattern to transmit through the skin into the treatment site. FDA UDI
- Model / Reference
- ManaMed Ultrasound Coupling Gel FDA UDI
- Description
- This Ultrasound Coupling Gel is to be used with our ManaSport+ product or any other Ultrasound devices or non-adhesive electrodes. This allows the wave pattern to transmit through the skin into the treatment site. FDA UDI
Identifiers
- Catalog Number
- MANAGEL01 FDA UDI
- Primary DI / UDI-DI
- 00810113688473 FDA UDI
- FDA Product Code
- MUI FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin topical coupling gel
ManaMed Inc by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin topical coupling gel.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Ecogel 200 — Eco-Med Pharmaceutical Inc · Class II
- Clear Image Singles — NEXT Medical Products Company · Class II
- Pharmaceutical Innovations — Pharmaceutical Innovations, Inc. · Class II
- DynaGel™ Ultrasound Gel, 5 Liters, Clear — Dynatronics Corp. · Class II
- RED Medical Supplies — Red Medical Supplies Ltd · Class II
- LG — COMPASS HEALTH BRANDS CORP. · Class II
- Novaplus — NEXT Medical Products Company · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI fb71c7b6-0c26-40de-8cd9-61a54b1b5218 35 fields · synced May 30, 2026