ACURUS

GUDID M454AR402P1551

POSTERIOR CHAMBER INTRAOCULAR LENS

EYEKON MEDICAL, INC.

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: M454AR402P1551
• NIH Device Record Key: 85f272b5-9d3c-4c79-8da1-a1862e4a55a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACURUS
• Version Model Number: AR40-2-15.5
• Company DUNS: 803926252
• Company Name: EYEKON MEDICAL, 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	M454AR402P1551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880072

FDA Product Code

• HQL: Intraocular Lens

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-08
• Device Publish Date: 2015-09-18

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• M454ARN55P2551: POSTERIOR CHAMBER INTRAOCULAR LENS
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• M454ARN55P1201: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454ARN55P1151: POSTERIOR CHAMBER INTRAOCULAR LENS
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• M454ARN55P1051: POSTERIOR CHAMBER INTRAOCULAR LENS
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• M454ARN55P0951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454ARN55P0901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454ARN55P0851: POSTERIOR CHAMBER INTRAOCULAR LENS
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• M454ARN55P0751: POSTERIOR CHAMBER INTRAOCULAR LENS
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• M454ARN55P0651: POSTERIOR CHAMBER INTRAOCULAR LENS
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