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 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 ID: 00841542101332
• NIH Device Record Key: 40103228-354d-4986-82ff-9fb74563c197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elastimide UV-Absorbing Silicone Three-Piece Posterior Chamber Intraocular Lens
• Version Model Number: AQ5010V
• Company DUNS: 054751110
• Company Name: STAAR SURGICAL COMPANY
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841542101332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880091

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: 2015-10-20

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

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