NA

Basic Information

• Brand Name: NA
• Primary DI: 05060191071291
• Version / Model: 1530678
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 841d38d7-18bf-48e5-b593-eea68c2e282d
• Distribution End Date: 2018-01-12

Device Description

TEST ACK3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060191071291	GS1

Customer Contacts

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