Identity
- Trade Name
- Sonicshield FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Sonicshield Antimicrobial Ultrasound Gel 20G FDA UDI
- Model / Reference
- SONX020X FDA UDI
- Description
- Sonicshield Antimicrobial Ultrasound Gel 20G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628108100363 FDA UDI
- 510(k) Number
- K151070 FDA UDI
- FDA Product Code
- ITX 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
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
Sonicshield by National Therapy Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151070 also covers:
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
- National Therapy Products, Inc.
Sources (1)
- FDA UDI cf8a8b00-d5e7-44d0-acbd-19978bd0aa40 35 fields · synced May 30, 2026