Leksell Gamma Knife Icon

Basic Information

• Brand Name: Leksell Gamma Knife Icon
• Primary DI: 07340048311588
• Version / Model: 1539744
• Catalog Number: 1030758
• Company Name: Elekta Instrument AB
• Labeler DUNS: 507772663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-09-16
• Public Version: 3
• Public Version Date: 2019-11-01
• Public Version Status: Update
• Public Device Record Key: ab870d42-0397-48c0-8ea7-f8a12f18f548

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: 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: 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
Package	07340048304917	GS1		10	In Commercial Distribution
Primary	07340048311588	GS1
Unit of Use	07340048305570	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 40 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 27 Degrees Celsius