DMV Luma Serter Plus 424

GUDID 00080875974248

45 degree Inserter for large contact lenses to be used with a pen light. No suction

DMV CORPORATION

Rigid contact lens inserter/remover

• Primary Device ID: 00080875974248
• NIH Device Record Key: abd4a30c-0347-4654-917b-d0c3377cae94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DMV Luma Serter Plus
• Version Model Number: 424
• Catalog Number: 424
• Company DUNS: 084436906
• Company Name: DMV CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00080875974248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830496

FDA Product Code

• KYE: Inserter/Remover Contact Lens

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: 2020-04-14
• Device Publish Date: 2020-04-06

Devices Manufactured by DMV CORPORATION

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• 00080875971100 - DMV Vented Scleral Cup: 2020-05-12 Contact lens Inserter with air channel for inserting hybrid, large soft and gp contact lenses. No suction
• 00080875975016 - DMV Traditional: 2020-05-12 Contact lens remover for hard and gp contact lenses
• 00080875975955 - DMV Classic: 2020-05-12 Contact lens remover/inserter with suction bulb for hard and gp contact lenses
• 00080875985916 - DMV Ultra: 2020-05-12 Contact lens remover/inserter for hard and gp contact lenses
• 00080875974231 - DMV Luma Serter: 2020-04-14 Inserter for contact lenses to be used with pen light. No suction
• 00080875974248 - DMV Luma Serter Plus: 2020-04-1445 degree Inserter for large contact lenses to be used with a pen light. No suction
• 00080875974248 - DMV Luma Serter Plus: 2020-04-14 45 degree Inserter for large contact lenses to be used with a pen light. No suction
• 00080875975160 - DMV Magic Touch: 2020-04-14 Contact lens remover/inserter with small air channel for hard and gp contact lenses. Suction is optional