PMMA

GUDID 00858174006003

PMMA (polymethyl methacrylate) hard contact lens for daily wear

LAGADO CORPORATION, THE

Hard corrective contact lens

• Primary Device ID: 00858174006003
• NIH Device Record Key: 73399476-58cb-47ab-a9a2-2ac48efda11e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMMA
• Version Model Number: 003
• Company DUNS: 109884150
• Company Name: LAGADO CORPORATION, THE
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858174006003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895411

FDA Product Code

• HPX: Lens, Contact (Polymethylmethacrylate)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-29

Devices Manufactured by LAGADO CORPORATION, THE

• 00858174006003 - PMMA: 2018-07-06PMMA (polymethyl methacrylate) hard contact lens for daily wear
• 00858174006003 - PMMA: 2018-07-06 PMMA (polymethyl methacrylate) hard contact lens for daily wear
• 00858174006010 - SA-18: 2018-07-06 SA-18 Silicone Acrylate daily wear contact lens
• 00858174006027 - SA-32: 2018-07-06 SA-32 Fluoro-silicone Acrylate daily wear contact lens
• 00858174006034 - FLOSI: 2018-07-06 FLOSI Fuoro-silicone Acrylat daily wear contact lens
• 00858174006041 - ONSI-56: 2018-07-06 ONSI-56 Fluoro-silicone acrylate daily wear contact lens
• 00858174006058 - TYRO-97: 2018-03-29 TYRO-97 Fluoro-silicone acrylate daily wear contact lens
• 00858174006522 - OP-2: 2018-03-29 OP-2 Fluoro-silicone Acrylate daily wear contact lens
• 00858174006539 - OP-3: 2018-03-29 OP-3 Fluoro-silicone Acrylate daily wear contact lens