QLRAD

Basic Information

• Brand Name: QLRAD
• Primary DI: 08720892233028
• Version / Model: 105.3000
• Company Name: QLRAD INTERNATIONAL LTD
• Labeler DUNS: 534509598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-01
• Public Version: 1
• Public Version Date: 2024-04-09
• Public Version Status: New
• Public Device Record Key: 136e271e-609b-41a0-9210-fce96bab3618

Device Description

Inframammary Fold Breast Wedge Large

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 Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KPY	Shield, Protective, Personnel	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64135	Patient radiation shielding pad/drape, reusable	A protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers.. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08720892233035	GS1	Box	10	In Commercial Distribution
Primary	08720892233028	GS1

Customer Contacts

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