Sonata® IUUS Probe Connector Protector

Basic Information

• Brand Name: Sonata® IUUS Probe Connector Protector
• Primary DI: 10817929020463
• Version / Model: ACCY-018
• Catalog Number: ACCY-018
• Company Name: GYNESONICS, INC.
• Labeler DUNS: 618493741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: 342f3116-9c15-4d2d-9505-8a4f58be7bb3

Device Description

Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the IUUS Probe during liquid reprocessing procedures.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48122	Non-submersible device disinfection chamber	A vessel designed to protect the part of a device that cannot be exposed to liquid cleaning agents or disinfectant [e.g., the electrical connector of a transoesophageal echocardiography (TOE) probe] in a water-tight vault that may be air-pressurized, so the patient-contact part of the device can be nonthermally, chemically decontaminated and/or high-level disinfected (e.g., in an automated endoscope washer/disinfector). It is typically made of metals and polymers [e.g., stainless steel, silicone, and polycarbonate (PC)] and consists of a housing with a clamp, seal, cap, and/or valves. It is typically used in instrument and endoscopy cleaning rooms. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817929020463	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K222304	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius