EYEKON

GUDID M454S117NP1401

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: M454S117NP1401
• NIH Device Record Key: 1aea9bb6-d1c9-4747-a9bf-b14617897cd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EYEKON
• Version Model Number: S117-N-14.0
• 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	M454S117NP1401 [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

On-Brand Devices [EYEKON]

• M454S211P3001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2551: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2501: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2451: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2401: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2351: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2301: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2251: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2201: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2151: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2101: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2051: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P2001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1551: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1501: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1451: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1401: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1351: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1301: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1251: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1201: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1151: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1101: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1051: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P1001: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0951: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0901: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0851: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0801: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0751: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0701: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0651: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0601: POSTERIOR CHAMBER INTRAOCULAR LENS
• M454S211P0551: POSTERIOR CHAMBER INTRAOCULAR LENS