Sonata® Intrauterine Ultrasound Probe Return Kit

Basic Information

• Brand Name: Sonata® Intrauterine Ultrasound Probe Return Kit
• Primary DI: 10817929020036
• Version / Model: RTN-001
• Catalog Number: RTN-001
• Company Name: GYNESONICS, INC.
• Labeler DUNS: 618493741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-07
• Public Version: 1
• Public Version Date: 2020-10-15
• Public Version Status: New
• Public Device Record Key: 4db97bf0-ba97-4a47-8284-5d8c1bb3df1b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
35561	Specimen container mailer, non-insulated	A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817929020036	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173703	000

Storage Conditions

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