Kobold® Tandem and 60 Deg Ring Applicator Set (E)

Basic Information

• Brand Name: Kobold® Tandem and 60 Deg Ring Applicator Set (E)
• Primary DI: 00815568020045
• Version / Model: 707-002
• Company Name: KOBOLD, LLC
• Labeler DUNS: 014292258
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: da196941-6218-47d1-bcc7-d756c26a21ae

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
38409	Cervical/intrauterine brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This GMDN code includes a wide 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
Primary	00815568020045	GS1

Premarket Submissions

Submission Number	Supplement Number
K142330	000

Device Sizes

Type	Value	Unit	Text
Angle	60	degree