Elastimide UV-Absorbing Silicone Three-Piece Posterior Chamber Intraocular Lens

GUDID 00841542101332

Diopter: -3.0 Plano/Concave; Three Piece

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, pseudophakic
Primary Device ID00841542101332
NIH Device Record Key40103228-354d-4986-82ff-9fb74563c197
Commercial Distribution StatusIn Commercial Distribution
Brand NameElastimide UV-Absorbing Silicone Three-Piece Posterior Chamber Intraocular Lens
Version Model NumberAQ5010V
Company DUNS054751110
Company NameSTAAR SURGICAL COMPANY
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 Identifiers

Device Issuing AgencyDevice ID
GS100841542101332 [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 Date2015-10-20

On-Brand Devices [Elastimide UV-Absorbing Silicone Three-Piece Posterior Chamber Intraocular Lens]

00841542101356Diopter: -4.0 Plano/Concave; Three Piece
00841542101349Diopter: 4.0 Convex/Plano; Three Piece
00841542101332Diopter: -3.0 Plano/Concave; Three Piece
00841542101325Diopter: 3.0 Convex/Plano; Three Piece
00841542101318Diopter: -2.0 Plano/Concave; Three Piece
00841542101301Diopter: 2.0 Convex/Plano; Three Piece
00841542101295Diopter: -1.0 Plano/Concave; Three Piece
00841542101288Diopter: 1.0 Convex/Plano; Three Piece
00841542101271Diopter: 0.0 Plano/Plano; Three Piece

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