iSert Intraocular Lens

GUDID 04547480351506

HOYA MEDICAL SINGAPORE PTE. LTD.

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 04547480351506
• NIH Device Record Key: ef1abae4-7d70-4314-bab8-8a3e77a2768c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSert Intraocular Lens
• Version Model Number: 231 (yellow), +29.50D
• 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	04547480351506 [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 [iSert Intraocular Lens]

• 04547480480985: 250 (clear), +30.00D
• 04547480480978: 250 (clear), +29.50D
• 04547480480961: 250 (clear), +29.00D
• 04547480480954: 250 (clear), +28.50D
• 04547480480947: 250 (clear), +28.00D
• 04547480480930: 250 (clear), +27.50D
• 04547480480923: 250 (clear), +27.00D
• 04547480480916: 250 (clear), +26.50D
• 04547480480909: 250 (clear), +26.00D
• 04547480480893: 250 (clear), +25.50D
• 04547480480886: 250 (clear), +25.00D
• 04547480480879: 250 (clear), +24.50D
• 04547480480862: 250 (clear), +24.00D
• 04547480480855: 250 (clear), +23.50D
• 04547480480848: 250 (clear), +23.00D
• 04547480480831: 250 (clear), +22.50D
• 04547480480824: 250 (clear), +22.00D
• 04547480480817: 250 (clear), +21.50D
• 04547480480800: 250 (clear), +21.00D
• 04547480480794: 250 (clear), +20.50D
• 04547480480787: 250 (clear), +20.00D
• 04547480480770: 250 (clear), +19.50D
• 04547480480763: 250 (clear), +19.00D
• 04547480480756: 250 (clear), +18.50D
• 04547480480749: 250 (clear), +18.00D
• 04547480480732: 250 (clear), +17.50D
• 04547480480725: 250 (clear), +17.00D
• 04547480480718: 250 (clear), +16.50D
• 04547480480701: 250 (clear), +16.00D
• 04547480480695: 250 (clear), +15.50D
• 04547480480688: 250 (clear), +15.00D
• 04547480480671: 250 (clear), +14.50D
• 04547480480664: 250 (clear), +14.00D
• 04547480480657: 250 (clear), +13.50D
• 04547480480640: 250 (clear), +13.00D
• 04547480480633: 250 (clear), +12.50D
• 04547480480626: 250 (clear), +12.00D
• 04547480480619: 250 (clear), +11.50D
• 04547480480602: 250 (clear), +11.00D
• 04547480480596: 250 (clear), +10.50D
• 04547480480589: 250 (clear), +10.00D
• 04547480480572: 250 (clear), +9.50D
• 04547480480565: 250 (clear), +9.00D
• 04547480480558: 250 (clear), +8.50D
• 04547480480541: 250 (clear), +8.00D
• 04547480480534: 250 (clear), +7.50D
• 04547480480527: 250 (clear), +7.00D
• 04547480480510: 250 (clear), +6.50D
• 04547480480503: 250 (clear), +6.00D
• 04547480450490: 251 (yellow), +30.00D