AERIN MEDICAL INC.

Address:2565 Leghorn St.,Mountain View,CA,94043,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

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Sterile Aquasonic 100 Ultrasound Transmission Gel - 28886479300157 Catalog Number : CAT447-Q06

Device Description : Sterile Aquasonic 100 Ultrasound Transmission Gel may be used:• On or near broke 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.

Device Class :

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 6

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