UNFOLDER EMERALD AR 1CART30

GUDID 15050474534466

MODEL 1CART30 CARTRIDGE

JOHNSON & JOHNSON SURGICAL VISION, INC.

Intraocular lens-insertion cartridge

• Primary Device ID: 15050474534466
• NIH Device Record Key: fbd7bf68-917a-4060-b2c8-8f28164b02d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNFOLDER EMERALD AR
• Version Model Number: 1CART30
• Catalog Number: 1CART30
• Company DUNS: 103021940
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05050474534469 [Primary]
GS1	15050474534466 [Package]; Contains: 05050474534469; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961242

FDA Product Code

• KYB: LENS, GUIDE, INTRAOCULAR

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-26
• Device Publish Date: 2019-02-13

Devices Manufactured by JOHNSON & JOHNSON SURGICAL VISION, INC.

• 05050474807433 - HEALON PRO: 2024-04-16 HEALON PRO 0,55 ML US
• 05050474807440 - HEALON PRO: 2024-04-16 HEALON PRO 0,85 ML US
• 05050474807457 - HEALON GV PRO: 2024-04-16 HEALON GV PRO 0,85 ML US
• 05050474807464 - HEALON5 PRO: 2024-04-16 HEALON5 PRO 0,6 ML US
• 05050474812765 - TECNIS ODYSSEY TORIC II IOL: 2024-02-01 TEC ODYSSEY TOR II SMPCY 31.5D CYL3.00
• 05050474812888 - TECNIS ODYSSEY TORIC II IOL: 2024-02-01 TEC ODYSSEY TOR II SMPCY 08.0D CYL3.75
• 05050474811058 - TECNIS ODYSSEY TORIC II IOL: 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.0D CYL1.50
• 05050474811065 - TECNIS ODYSSEY TORIC II IOL: 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.5D CYL1.50