Leksell Gamma Knife Icon

Basic Information

• Brand Name: Leksell Gamma Knife Icon
• Primary DI: 07340048304924
• Version / Model: 1524411
• Company Name: Elekta Instrument AB
• Labeler DUNS: 507772663
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 03bac7f6-1434-48a2-9bb7-ac1f4f688e76
• Distribution End Date: 2018-10-18

Device Description

PATIENT MARKERS (10 PCS)

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: MR Safe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWB	System, radiation therapy, radionuclide	Radiology	892.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38297	Teletherapy radionuclide system, conventional	A stationary assembly of computer-based devices designed to deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source, typically to treat malignant tumours; it does not provide image-guided radiation therapy (IGRT) functionality during treatment delivery. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source); 2) a rotating or fixed gantry with the treatment head; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table; and 5) an operator's console with controls. It is commonly known as a cobalt therapy machine.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340048304924	GS1
Unit of Use	07340048305570	GS1

Customer Contacts

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