NA

Basic Information

• Brand Name: NA
• Primary DI: 08717213036611
• Version / Model: 137064P01-02
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f563f147-7f8a-478d-9f6e-a8aa56b7d5c2

Device Description

Flexitron Adapter for 5F Catheters

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
38437	Brachytherapy system remote afterloading source transfer tube	A tube or hose-like catheter with connectors at both ends used to interface the brachytherapy applicator to the remote afterloading system. The transfer tube, when attached to the applicator and the afterloading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote afterloading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient.	No	Active
38411	Bronchial brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in bronchial radiation therapy treatments. It is designed for temporary placement within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the bronchial area. 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
Direct Marking	08717213022003	GS1
Primary	08717213036611	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070574	000
K082530	000
K132874	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	5.0	French
Device Size Text, specify

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius