Best Medical International

Basic Information

• Brand Name: Best Medical International
• Primary DI: 00841365116223
• Version / Model: 1264-3
• Company Name: BEST MEDICAL INTERNATIONAL, INC.
• Labeler DUNS: 086352655
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-12
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: f121832d-74a2-4acc-ae84-2a6ed44907aa

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: 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
IWJ	System, Applicator, Radionuclide, Manual	Radiology	892.5650	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38428	Bladder brachytherapy system applicator, manual	A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the bladder. It is an individual device designed to facilitate manual placement, e.g., endoscopically guided or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site within the bladder. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes bladder applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841365116223	GS1

Premarket Submissions

Submission Number	Supplement Number
K910862	000