Leksell GammaPlan

Basic Information

• Brand Name: Leksell GammaPlan
• Primary DI: 07340048311229
• Version / Model: 1529604
• Catalog Number: 1529980
• Company Name: Elekta Instrument AB
• Labeler DUNS: 507772663
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-18
• Public Version: 5
• Public Version Date: 2019-08-12
• Public Version Status: Update
• Public Device Record Key: b1f44554-4828-4e8e-b94f-66307f232417
• Distribution End Date: 2018-11-01

Device Description

LGP 11.1 SW MEDIA

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MUJ	System, planning, radiation therapy treatment	Radiology	892.5050	2
IWB	System, radiation therapy, radionuclide	Radiology	892.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40885	Stereotactic system application software	An application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340048311229	GS1

Customer Contacts

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