Sonicision

Basic Information

• Brand Name: Sonicision
• Primary DI: 10884521592902
• Version / Model: SCBIGA
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-22
• Public Version: 4
• Public Version Date: 2022-05-27
• Public Version Status: Update
• Public Device Record Key: 8395103d-ea97-4d3e-856d-72d68f815886

Device Description

Reusable Battery Insertion Guide

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
60486	Surgical instrument battery insertion guide	A non-sterile device intended to protect a sterile, battery-powered surgical instrument during insertion of a non-sterile battery such that the sterility of the surgical instrument is maintained; it may be intended for use preoperatively and/or during surgery. It is typically a shaped template which is designed to fit and cover the profile of the battery insertion port. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521592909	GS1	PACK_OR_INNER_PACK	2	In Commercial Distribution
Primary	10884521592902	GS1
Package	30884521592906	GS1	CASE	16	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180149	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit