iSymm Intraocular Lens

GUDID 04547480104164

HOYA MEDICAL SINGAPORE PTE. LTD.

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 04547480104164
• NIH Device Record Key: d830ee6e-a8ae-453e-86d1-5950ff94f637
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSymm Intraocular Lens
• Version Model Number: FC-60AD (clear), +26.00D
• Company DUNS: 894831895
• Company Name: HOYA MEDICAL SINGAPORE PTE. LTD.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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 Dimensions

• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547480104164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080004

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [iSymm Intraocular Lens]

• 04547480203324: FY-60AD (yellow), +30.00D
• 04547480203317: FY-60AD (yellow), +29.50D
• 04547480203300: FY-60AD (yellow), +29.00D
• 04547480203294: FY-60AD (yellow), +28.50D
• 04547480203287: FY-60AD (yellow), +28.00D
• 04547480203270: FY-60AD (yellow), +27.50D
• 04547480203263: FY-60AD (yellow), +27.00D
• 04547480203256: FY-60AD (yellow), +26.50D
• 04547480203249: FY-60AD (yellow), +26.00D
• 04547480203232: FY-60AD (yellow), +25.50D
• 04547480203225: FY-60AD (yellow), +25.00D
• 04547480203218: FY-60AD (yellow), +24.50D
• 04547480203201: FY-60AD (yellow), +24.00D
• 04547480203195: FY-60AD (yellow), +23.50D
• 04547480203188: FY-60AD (yellow), +23.00D
• 04547480203171: FY-60AD (yellow), +22.50D
• 04547480203164: FY-60AD (yellow), +22.00D
• 04547480203157: FY-60AD (yellow), +21.50D
• 04547480203140: FY-60AD (yellow), +21.00D
• 04547480203133: FY-60AD (yellow), +20.50D
• 04547480203126: FY-60AD (yellow), +20.00D
• 04547480203119: FY-60AD (yellow), +19.50D
• 04547480203102: FY-60AD (yellow), +19.00D
• 04547480203096: FY-60AD (yellow), +18.50D
• 04547480203089: FY-60AD (yellow), +18.00D
• 04547480203072: FY-60AD (yellow), +17.50D
• 04547480203065: FY-60AD (yellow), +17.00D
• 04547480203058: FY-60AD (yellow), +16.50D
• 04547480203041: FY-60AD (yellow), +16.00D
• 04547480203034: FY-60AD (yellow), +15.50D
• 04547480203027: FY-60AD (yellow), +15.00D
• 04547480203010: FY-60AD (yellow), +14.50D
• 04547480203003: FY-60AD (yellow), +14.00D
• 04547480202990: FY-60AD (yellow), +13.50D
• 04547480202983: FY-60AD (yellow), +13.00D
• 04547480202976: FY-60AD (yellow), +12.50D
• 04547480202969: FY-60AD (yellow), +12.00D
• 04547480202952: FY-60AD (yellow), +11.50D
• 04547480202945: FY-60AD (yellow), +11.00D
• 04547480202938: FY-60AD (yellow), +10.50D
• 04547480202921: FY-60AD (yellow), +10.00D
• 04547480202914: FY-60AD (yellow), +9.50D
• 04547480202907: FY-60AD (yellow), +9.00D
• 04547480202891: FY-60AD (yellow), +8.50D
• 04547480202884: FY-60AD (yellow), +8.00D
• 04547480202877: FY-60AD (yellow), +7.50D
• 04547480202860: FY-60AD (yellow), +7.00D
• 04547480202853: FY-60AD (yellow), +6.50D
• 04547480202846: FY-60AD (yellow), +6.00D
• 04547480104249: FC-60AD (clear), +30.00D