Sonic Window Sterile Transducer Cover

Basic Information

• Brand Name: Sonic Window Sterile Transducer Cover
• Primary DI: 90814277020127
• Version / Model: 21-05012-01
• Company Name: ANALOGIC CORPORATION
• Labeler DUNS: 019677418
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 5
• Public Version Date: 2018-12-21
• Public Version Status: Update
• Public Device Record Key: e42cf25f-ff6c-4715-89fa-feed633e5c64

Device Description

Sterile Transducer Cover - individual cover in envelope

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60924	Hand-held ultrasound imaging system, body-surface	A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	90814277020127	GS1
Package	90814277020134	GS1		50	In Commercial Distribution
Package	90814277020141	GS1		5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140126	000