iSert Intraocular Lens

GUDID 04547480480800

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 ID04547480480800
NIH Device Record Key0d3b2f2f-f2ba-4a5b-9bb6-968fb4fce0b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameiSert Intraocular Lens
Version Model Number250 (clear), +21.00D
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
GS104547480480800 [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 [iSert Intraocular Lens]

04547480480985250 (clear), +30.00D
04547480480978250 (clear), +29.50D
04547480480961250 (clear), +29.00D
04547480480954250 (clear), +28.50D
04547480480947250 (clear), +28.00D
04547480480930250 (clear), +27.50D
04547480480923250 (clear), +27.00D
04547480480916250 (clear), +26.50D
04547480480909250 (clear), +26.00D
04547480480893250 (clear), +25.50D
04547480480886250 (clear), +25.00D
04547480480879250 (clear), +24.50D
04547480480862250 (clear), +24.00D
04547480480855250 (clear), +23.50D
04547480480848250 (clear), +23.00D
04547480480831250 (clear), +22.50D
04547480480824250 (clear), +22.00D
04547480480817250 (clear), +21.50D
04547480480800250 (clear), +21.00D
04547480480794250 (clear), +20.50D
04547480480787250 (clear), +20.00D
04547480480770250 (clear), +19.50D
04547480480763250 (clear), +19.00D
04547480480756250 (clear), +18.50D
04547480480749250 (clear), +18.00D
04547480480732250 (clear), +17.50D
04547480480725250 (clear), +17.00D
04547480480718250 (clear), +16.50D
04547480480701250 (clear), +16.00D
04547480480695250 (clear), +15.50D
04547480480688250 (clear), +15.00D
04547480480671250 (clear), +14.50D
04547480480664250 (clear), +14.00D
04547480480657250 (clear), +13.50D
04547480480640250 (clear), +13.00D
04547480480633250 (clear), +12.50D
04547480480626250 (clear), +12.00D
04547480480619250 (clear), +11.50D
04547480480602250 (clear), +11.00D
04547480480596250 (clear), +10.50D
04547480480589250 (clear), +10.00D
04547480480572250 (clear), +9.50D
04547480480565250 (clear), +9.00D
04547480480558250 (clear), +8.50D
04547480480541250 (clear), +8.00D
04547480480534250 (clear), +7.50D
04547480480527250 (clear), +7.00D
04547480480510250 (clear), +6.50D
04547480480503250 (clear), +6.00D
04547480450490251 (yellow), +30.00D

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