NA

Basic Information

• Brand Name: NA
• Primary DI: 08717213025042
• Version / Model: 189638-00
• 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: 8f955759-5bee-4b73-9982-f07830222a65

Device Description

ProGuide Sharp Needle 6Fx200mm

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
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08717213025363	GS1		1	In Commercial Distribution
Package	08717213025356	GS1		1	In Commercial Distribution
Primary	08717213025042	GS1
Package	08717213025349	GS1		1	In Commercial Distribution
Unit of Use	08717213025059	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K003270	000
K060349	000

Device Sizes

Type	Value	Unit	Text
Length	200.0	Millimeter
Catheter Gauge	6.0	French