superDimension

Basic Information

• Brand Name: superDimension
• Primary DI: 10884521785861
• Version / Model: ILS-0726-PS
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-24
• Public Version: 3
• Public Version Date: 2021-11-02
• Public Version Status: Update
• Public Device Record Key: 646445b8-e61d-45ef-899f-0f9ea001c5d4

Device Description

superDimension Planning Station

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: 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: No
• 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
JAK	System, x-ray, tomography, computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38453	Portable computer	A portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard and/or touchscreen integrated into one unit in the form of a laptop, tablet, palmtop or other hand-held (including smartphone) device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521785861	GS1

Customer Contacts

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