GONAD SHIELD

Basic Information

• Brand Name: GONAD SHIELD
• Primary DI: 00840186698482
• Version / Model: GONADSHIELD-SLGS2-TRI-NONE
• Company Name: BURLINGTON MEDICAL, LLC
• Labeler DUNS: 083381202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-23
• Public Version: 1
• Public Version Date: 2022-10-03
• Public Version Status: New
• Public Device Record Key: a796bf64-8008-4f3b-99ba-eda69953fb25

Device Description

GONAD SHIELD, .35MM LEAD, SMALL, TRIANGULAR, NO STRAP

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
IWT	Shield, Gonadal	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38367	Gonad radiation shield	A personal protective device intended to shield the gonads of an individual (i.e., a device operator, patient, or other attending person) from unnecessary exposure to radiation from diagnostic medical and dental procedures by providing an attenuating barrier to the radiation. It comes in various configurations: 1) anatomically designed to fit over the gonads; 2) placed directly on the body; or 3) attached to the wall or radiation delivery device on an articulating arm. Radiation protection male and female gonadal shields are typically made of lead (Pb) or lead-equivalent material.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840186698482	GS1