Guidance ultrasound transducer sleeve

Basic Information

• Brand Name: Guidance ultrasound transducer sleeve
• Primary DI: 00854763006058
• Version / Model: 5500
• Catalog Number: 5500
• Company Name: HALT MEDICAL, INC
• Labeler DUNS: 602783495
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cd7e47b0-a49d-41eb-b1c9-6106e7b2e0e7

Device Description

Sterile Disposable Guidance Ultrasound Transducer Sleeve

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	884.4160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57972	Radio-frequency ablation system	An assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854763006058	GS1

Customer Contacts

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