AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed

Basic Information

• Brand Name: AOS Implant Tube, Breast/Head/Neck, Puthawala/Syed
• Primary DI: 00850645007137
• Version / Model: TIB0001-003
• Company Name: ALPHA-OMEGA SERVICES, INC.
• Labeler DUNS: 060398989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: fd36ec78-45ad-42fb-a7a8-42736aa1ad90

Device Description

Implant Tube, Breast/Head/Neck, Puthawala/Syed, 28 cm Leader, 25 cm Body, with Female Luer Adaptor, Cable Insert, with Green Nylon Retaining Buttons and Stainless Steel Retaining Buttons, 20 ea

Device Characteristics

• Single Use: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

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
38419	Neck brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the neck. It is designed for temporary topical placement on or implantation within the neck tissue 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
60421	Breast brachytherapy system applicator, remote-afterloading	A sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850645007137	GS1
Unit of Use	00850645007717	GS1