Bolle

GUDID 00840331296501

SPICY GLASSES, PROGRESSIVE, .75MM PB EQ

BURLINGTON MEDICAL, LLC

Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles

• Primary Device ID: 00840331296501
• NIH Device Record Key: ecae043b-a9d2-4000-a2bb-4cb7dea9cad2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bolle
• Version Model Number: EW-0005-PRG
• Company DUNS: 083381202
• Company Name: BURLINGTON MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840331296501 [Primary]

FDA Product Code

• IWS: Shield, Eye, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [Bolle]

• 00840331296501: SPICY GLASSES, PROGRESSIVE, .75MM PB EQ
• 00840331296495: SPICY GLASSES, BIFOCAL, .75MM PB EQ
• 00840331296488: SPICY GLASSES, SINGLE VISION, .75MM PB EQ
• 00840331296471: SPICY GLASSES, NON RX, .75MM PB EQ