Bollé Brands

GUDID 00840332215785

BOLLE BRANDS (FRANCE)

Prescription spectacles

• Primary Device ID: 00840332215785
• NIH Device Record Key: 1015470a-3afd-4882-af72-fc3bd887ac1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bollé Brands
• Version Model Number: Winslow 2.0
• Company DUNS: 551672785
• Company Name: BOLLE BRANDS (FRANCE)
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	00840332215785 [Primary]

FDA Product Code

• HQG: Lens, Spectacle, Non-Custom (Prescription)

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: 2025-10-03
• Device Publish Date: 2025-09-25

On-Brand Devices [Bollé Brands]

• 00054917321512: LIGHTSHIFTER Black Matte - Frame Only
• 00054917321475: Pathfinder RX Frame
• 00054917321383: Ascender RX Frame
• 00054917312503: STRIX Black Matte - Frame Only
• 00054917312374: LIGHTSHIFTER XL Black Matte - Frame Only
• 00054917312367: LIGHTSHIFTER XL Titanium Matte - Frame Only
• 00054917312329: LIGHTSHIFTER Titanium Matte - Frame Only
• 00054917312213: BOLT 2.0 S Black Crystal Matte - Frame Only
• 00054917312107: ANACONDA Black Matte - Frame Only
• 00054917308353: Baller RX Frame
• 00054917303433: Swag Strap RX Frame
• 00054917303426: Swag Strap RX Frame
• 00054917303419: Swag RX Frame
• 00054917303402: Swag RX Frame
• 00054917303372: Coverage RX Frame
• 00054917303365: Coverage RX Frame
• 00054917288297: ANACONDA Black Shiny - Frame Only
• 00029757235015: Bormio
• 03660740025618: PCPOLX02A
• 03660740025601: PXLDEGS-C01
• 03660740025595: HI167X17W
• 03660740025588: PXLPROS-C01
• 03660740025571: PXLPROF-C01
• 03660740025564: PXLBIFFC01
• 03660740025557: PCBLUX05W
• 03660740025540: PXLPROS-101
• 03660740025533: PCSELX00W
• 03660740025526: PXLUNIZ-101
• 03660740025519: PCPOLX00A
• 03660740025502: PCPOLX50W
• 03660740025496: PCBLUX00W
• 03660740025489: PCBLUX03W
• 03660740025472: PCBLUX04W
• 03660740025465: PXLDEGS-101
• 03660740025458: SPHPLZGD6
• 03660740025441: PPHPLZGD6
• 03660740025434: PCSELX60W
• 03660740025427: SSEDONAP8
• 03660740025410: PSEDONAP6
• 03660740025403: SSEDONAP6
• 03660740025397: SDRIVERGR6
• 03660740025380: TRIVEX25W
• 03660740025373: TRIVEX55W
• 03660740025366: TWISLX20W
• 03660740025359: TWISLX50W
• 03660740025342: TRIVEX22W
• 03660740025335: TRIVEX52W
• 03660740025328: TRIVEX26W
• 03660740025311: TRIVEX56W
• 03660740025304: PCSELX50W