Paraperm EW

GUDID B22203

Paraperm® EW (pasifocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical,

PARAGON VISION SCIENCES, INC.

Rigid-gas-permeable corrective contact lens, daily-wear

• Primary Device ID: B22203
• NIH Device Record Key: d5978026-dd03-41e0-92c1-1d539463ea73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paraperm EW
• Version Model Number: Paraperm EW
• Company DUNS: 185530029
• Company Name: PARAGON VISION SCIENCES, INC.
• 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: 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
HIBCC	B22203 [Primary]

FDA Product Code

• MWL: Lens,Contact(Rigid Gas Permeable)-Extended Wear

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-23

Devices Manufactured by PARAGON VISION SCIENCES, INC.

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• B22222 - Paragon Z CRT Dual Axis: 2021-04-13 Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congrue
• B22202 - Paraperm O2: 2019-05-06 Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact