Fiducial Marker;Nitinol Coil

Fiducial Marker;Nitinol Coil
SuperLock - SDGN447

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.

• Width: 4.0 Millimeter
• Length: 7.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JAK

Device Name: System, X-Ray, Tomography, Computed

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: 892.1750

Third Party Flag: Y

Medical Specialty: RA

Device Id: 20884521762685

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521762688

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521762688

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