Identity
- Trade Name
- Sterile Aquasonic 100 Ultrasound Transmission Gel FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Sterile Aquasonic 100 Ultrasound Transmission Gel may be used: • On or near broken skin, such as fresh surgical site or open wound where sterility is indicated. • On mucous membranes and in natural body orifices. • For patients where cross contamination is a concern such as: • Patients with immunodeficiency or on immunosuppressive therapy. • Neonates or critically ill pediatric patients. • Critically ill patients or patients in contact, airborne or droplet transmission-based precautions. FDA UDI
- Model / Reference
- MS303 FDA UDI
- Description
- Sterile Aquasonic 100 Ultrasound Transmission Gel may be used: • On or near broken skin, such as fresh surgical site or open wound where sterility is indicated. • On mucous membranes and in natural body orifices. • For patients where cross contamination is a concern such as: • Patients with immunodeficiency or on immunosuppressive therapy. • Neonates or critically ill pediatric patients. • Critically ill patients or patients in contact, airborne or droplet transmission-based precautions. FDA UDI
Identifiers
- Catalog Number
- CAT447-Q06 FDA UDI
- Primary DI / UDI-DI
- 28886479300157 FDA UDI
- 510(k) Number
- K172529 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical system
Sterile Aquasonic 100 Ultrasound Transmission Gel by Aerin Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Aerin Medical Inc.
Sources (1)
- FDA UDI a8959ef7-30f2-4d3f-8d5e-a3a57d812cf2 36 fields · synced May 31, 2026