CT-Markers

Basic Information

• Brand Name: CT-Markers
• Primary DI: 08717213040281
• Version / Model: 189086P01-00
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-10-08
• Public Version: 4
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 6a2f2bf9-4cf1-4c8e-8eb3-6ee395dad0ae

Device Description

CT Marker 240 mm, Black

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
JAC	System, x-ray, film marking, radiographic	Radiology	892.1640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38436	General-purpose brachytherapy system applicator, remote-afterloading	A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08717213025288	GS1		2	In Commercial Distribution
Primary	08717213040281	GS1
Unit of Use	08717213025257	GS1
Package	08717213016903	GS1		6	In Commercial Distribution
Package	08717213020986	GS1		4	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify
Length	240.0	Millimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius