Identity
- Trade Name
- Novaplus FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Novaplus Ultrasound Gel, Medium Viscosity, 8 oz. FDA UDI
- Model / Reference
- V05-812 FDA UDI
- Description
- Novaplus Ultrasound Gel, Medium Viscosity, 8 oz. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30856724004494 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin topical coupling gel
Novaplus by NEXT Medical Products Company — 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
- 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
- ECO SUPERGEL — Ceracarta Spa · Class II
- Sonicshield — National Therapy Products, Inc. · 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
- NEXT Medical Products Company
Sources (1)
- FDA UDI d65e340d-d463-4675-a41f-10c0411b25d3 33 fields · synced May 30, 2026