Elastimide UV-Absorbing Silicone Posterior Chamber Intraocular Lens

GUDID 00841542100021

Diopter: 10.0 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: 00841542100021
• NIH Device Record Key: 7cf3911d-e70d-4b39-84d1-8b24c9241109
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elastimide UV-Absorbing Silicone Posterior Chamber Intraocular Lens
• Version Model Number: AQ2010V
• 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	00841542100021 [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 Posterior Chamber Intraocular Lens]

• 00841542101264: Diopter: 9.0 Three Piece
• 00841542101257: Diopter: 8.0 Three Piece
• 00841542101240: Diopter: 7.0 Three Piece
• 00841542101233: Diopter: 6.0 Three Piece
• 00841542101226: Diopter: 5.0 Three Piece
• 00841542100434: Diopter: 30.5 Three Piece
• 00841542100427: Diopter: 30.0 Three Piece
• 00841542100410: Diopter: 29.5 Three Piece
• 00841542100403: Diopter: 29.0 Three Piece
• 00841542100397: Diopter: 28.5 Three Piece
• 00841542100380: Diopter: 28.0 Three Piece
• 00841542100373: Diopter: 27.5 Three Piece
• 00841542100366: Diopter: 27.0 Three Piece
• 00841542100359: Diopter: 26.5 Three Piece
• 00841542100342: Diopter: 26.0 Three Piece
• 00841542100335: Diopter: 25.5 Three Piece
• 00841542100328: Diopter: 25.0 Three Piece
• 00841542100311: Diopter: 24.5 Three Piece
• 00841542100304: Diopter: 24.0 Three Piece
• 00841542100298: Diopter: 23.5 Three Piece
• 00841542100281: Diopter: 23.0 Three Piece
• 00841542100274: Diopter: 22.5 Three Piece
• 00841542100267: Diopter: 22.0 Three Piece
• 00841542100250: Diopter: 21.5 Three Piece
• 00841542100243: Diopter: 21.0 Three Piece
• 00841542100236: Diopter: 20.5 Three Piece
• 00841542100229: Diopter: 20.0 Three Piece
• 00841542100212: Diopter: 19.5 Three Piece
• 00841542100205: Diopter: 19.0 Three Piece
• 00841542100199: Diopter: 18.5 Three Piece
• 00841542100182: Diopter: 18.0 Three Piece
• 00841542100175: Diopter: 17.5 Three Piece
• 00841542100168: Diopter: 17.0 Three Piece
• 00841542100151: Diopter: 16.5 Three Piece
• 00841542100144: Diopter: 16.0 Three Piece
• 00841542100137: Diopter: 15.5 Three piece
• 00841542100120: Diopter: 15.0 Three piece
• 00841542100113: Diopter: 14.5 Three piece
• 00841542100106: Diopter: 14.0 Three piece
• 00841542100090: Diopter: 13.5 Three piece
• 00841542100083: Diopter: 13.0 Three piece
• 00841542100076: Diopter: 12.5 Three piece
• 00841542100069: Diopter: 12.0 Three piece
• 00841542100052: Diopter: 11.5 Three piece
• 00841542100045: Diopter: 11.0 Three piece
• 00841542100038: Diopter: 10.5 Three piece
• 00841542100021: Diopter: 10.0 Three piece
• 00841542100014: Diopter: 9.5 Three Piece