Identity
- Trade Name
- CLINICAL HEALTH SERVICES, INC. FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Ultrasound Lotion, Gallon with Dispenser FDA UDI
- Model / Reference
- CLID373X-Lotion FDA UDI
- Description
- Ultrasound Lotion, Gallon with Dispenser FDA UDI
Identifiers
- Catalog Number
- CLID373X-Lotion FDA UDI
- Primary DI / UDI-DI
- 00815290013872 FDA UDI
- 510(k) Number
- K013212 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
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
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
Clinical Health Services, Inc. by Clinical Health Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Skin topical coupling gel.
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- RED Medical Supplies — Red Medical Supplies Ltd · Class II
- LG — COMPASS HEALTH BRANDS CORP. · Class II
- Novaplus — NEXT Medical Products Company · Class II
Cleared under the same submission
K013212 also covers:
- Dynatron® Lotion, 1 Gallon — Dynatronics Corp.
- Sonigel Lotion with Aloe Vera — METTLER ELECTRONICS CORP.
- Sonigel Lotion with Aloe Vera — METTLER ELECTRONICS CORP.
- Wavelength — National Therapy Products, Inc.
- Wavelength — National Therapy Products, Inc.
- Wavelength — National Therapy Products, Inc.
- Wavelength — National Therapy Products, Inc.
- Scrip Hessco — Scriphessco
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
- Clinical Health Services, Inc.
Sources (1)
- FDA UDI 71073381-e43d-4fb0-a9bd-19de55f05b61 36 fields · synced May 30, 2026