Sonata® Procedure Kit

Basic Information

• Brand Name: Sonata® Procedure Kit
• Primary DI: 10817929020166
• Version / Model: PROKIT-001
• Catalog Number: PROKIT-001
• Company Name: GYNESONICS, INC.
• Labeler DUNS: 618493741
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-07
• Public Version: 2
• Public Version Date: 2022-07-19
• Public Version Status: Update
• Public Device Record Key: a6e12304-3933-417a-9045-626cf29d9819
• Distribution End Date: 2022-05-02

Device Description

Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	884.4160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60644	Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817929020166	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193516	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius