Fiducial Marker;3
superDimension - SDM3
Device Description
A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.
Environmental Conditions
- Keep dry
Device Sizes
- Outer Diameter: 0.9 Millimeter
- Length: 23 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: IYE
Device Name: Accelerator, Linear, Medical
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: RA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 892.5050
Third Party Flag: N
Medical Specialty: RA
Device IdentifiersDevice Id: 20884521198804
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521198807
Package Quantity: 5
Package Discontinue Date: 4/6/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: CASE
Device Id: 10884521198807
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A