Sterile Aquasonic 100 Ultrasound Transmission Gel

Basic Information

• Brand Name: Sterile Aquasonic 100 Ultrasound Transmission Gel
• Primary DI: 28886479300157
• Version / Model: MS303
• Catalog Number: CAT447-Q06
• Company Name: Aerin Medical Inc.
• Labeler DUNS: 051512253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2017-12-19
• Public Version: 8
• Public Version Date: 2023-04-21
• Public Version Status: Update
• Public Device Record Key: a8959ef7-30f2-4d3f-8d5e-a3a57d812cf2

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44776	Electrosurgical system	An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	28886479300157	GS1
Unit of Use	08886479300153	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172529	000