NA

Basic Information

• Brand Name: NA
• Primary DI: 08717213024991
• Version / Model: 189640-00
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2017-05-25
• Public Version: 5
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 7ac5fd13-4d02-4523-9cd5-b775b190eb94

Device Description

ProGuide Sharp Needle 5Fx240mm

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAQ	System, applicator, radionuclide, remote-controlled	Radiology	892.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38427	Prostate brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the prostate. It is designed for temporary implantation within the prostate and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.	No	Active
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	08717213025394	GS1		6	In Commercial Distribution
Package	08717213025400	GS1		12	In Commercial Distribution
Package	08717213025387	GS1		3	In Commercial Distribution
Primary	08717213024991	GS1
Unit of Use	08717213025004	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K003270	000
K060349	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	5.0	French
Length	240.0	Millimeter