QLRAD

Basic Information

• Brand Name: QLRAD
• Primary DI: 08719326258256
• Version / Model: 105.1001
• Company Name: QLRAD INTERNATIONAL LTD
• Labeler DUNS: 534509598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-14
• Public Version: 1
• Public Version Date: 2021-09-22
• Public Version Status: New
• Public Device Record Key: 78e838cc-5418-4642-bf76-689016c8ea96

Device Description

RectalPro75

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PCT	Prostate immobilizer rectal balloon	Radiology	892.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62434	Prostate immobilization balloon catheter	A non-sterile flexible tube with an inflatable balloon at its distal end intended to be inserted into the rectum to facilitate adequate positioning and immobilization of the prostate during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719326258256	GS1
Package	08719326258270	GS1	box	100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180478	000