Adjustable Flex Wide Belt Radiation Protection Apron-Pb Free-Medium

Basic Information

• Brand Name: Adjustable Flex Wide Belt Radiation Protection Apron-Pb Free-Medium
• Primary DI: 00850035588383
• Version / Model: AFWB-PbF-MD
• Company Name: Barrier Technologies, LLC
• Labeler DUNS: 621134084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-06
• Public Version: 1
• Public Version Date: 2022-10-14
• Public Version Status: New
• Public Device Record Key: 81a3c241-5717-4017-9111-4d412cb6d8d4

Device Description

The Adjustable Flex with Wide Belt radiation protection apron offers even weight distribution for less stress on the neck and back. 6” fully adjustable wide elastic belt shifts the weight of the apron from the shoulders to the hips. Fully adjustable back saver belt provides maximum support to the lower lumbar region. Velcro shoulder strap helps prevent slippage and shoulder pads provide additional comfort

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
EAJ	Apron, Leaded	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38355	Radiation shielding apron	A full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850035588383	GS1