Identity
- Trade Name
- Clear Image Singles Sterile FDA UDI
- Generic Name
- Topical coupling gel, sterile FDA UDI
- Device Name
- Clear Image Sterile Ultrasound Gel, 20ml FDA UDI
- Model / Reference
- 04-048-020 FDA UDI
- Description
- Clear Image Sterile Ultrasound Gel, 20ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30856724004166 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Topical coupling gel, sterile 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
Yes
FDA UDI
Single Use
Yes
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: Topical coupling gel, sterile
Clear Image Singles Sterile by NEXT Medical Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Topical coupling gel, sterile.
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, 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 df299b0f-0c01-4ead-8523-5af61cfa53b1 33 fields · synced May 30, 2026