iSymm Intraocular Lens

GUDID 04547480103952

HOYA MEDICAL SINGAPORE PTE. LTD.

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 Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic
Primary Device ID04547480103952
NIH Device Record Key164d3baf-b533-4f91-8072-c75f390833f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameiSymm Intraocular Lens
Version Model NumberFC-60AD (clear), +15.50D
Company DUNS894831895
Company NameHOYA MEDICAL SINGAPORE PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter
Outer Diameter12.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104547480103952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQLIntraocular Lens

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [iSymm Intraocular Lens]

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

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