Cap

Basic Information

• Brand Name: Cap
• Primary DI: 00840186610101
• Version / Model: RBCAP2S
• Company Name: BURLINGTON MEDICAL, LLC
• Labeler DUNS: 083381202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-23
• Public Version: 1
• Public Version Date: 2020-12-01
• Public Version Status: New
• Public Device Record Key: d6feae98-25e3-44b2-9140-d1c02b4b1315

Device Description

Cap - Standard Size with Velcro Closure .5mm Burlite Size Small

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: 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
45548	Radiation shielding head wear	A personal protective device intended to shield the head of an individual (i.e., the operator or other attending person) from unnecessary primary and scattered radiation during diagnostic or therapeutic medical procedures. It can be shaped like a cap or hood and will typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Head wear used for neutron attenuation is composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840186610101	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Small