UNITY 8065000243

GUDID 00380650002433

LASER KIT

Alcon Laboratories, Inc.

Phacoemulsification/vitrectomy system

• Primary Device ID: 00380650002433
• NIH Device Record Key: 8efeb498-9e42-4303-a388-785857b094fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNITY
• Version Model Number: 00380650002433
• Catalog Number: 8065000243
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00380650002433 [Primary]

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-11
• Device Publish Date: 2024-07-03

On-Brand Devices [UNITY]

• 10380657531797: 25+ 30K Vitrectomy Probe
• 10380657531681: Anterior Vitrectomy Kit 7.5CPM 25+GA
• 10380657531674: Anterior Vitrectomy Kit 7.5CPM 23GA
• 00380650003157: UNITY U/S HP
• 10380650002508: 27+ DS 30k Vit Probe
• 00380650002150: OZIL Fragmentation Handpiece
• 10380650001259: 22GA Fragmentation Pack
• 20380650004851: 25+ UNITY Comb Pack, NGES HyperVit 30K, WA, Ultra, 45° Balanced Tip
• 20380650004844: 25+ UNITY Comb Pack, NGES HyperVit 30K, WA, Ultra, 30° Balanced Tip
• 10380650003420: UNITY Cataract FMS Pack, 45° Hybrid Tip with Ultra Infusion Sleeves
• 10380650003413: UNITY Cataract FMS Pack, 30° Hybrid Tip with Ultra Infusion Sleeves
• 10380650003406: UNITY Cataract FMS Pack, 45° Balanced Tip with Ultra Infusion Sleeves
• 10380650003390: UNITY Cataract FMS Pack, 30° Balanced Tip with Ultra Infusion Sleeves
• 00380650002969: UNITY VCS System (Anterior/Posterior)
• 00380650002433: LASER KIT
• 10380657531766: 25+ ULTRAVIT 10K Probe
• 10380657531759: 25GA 10K Long Vitrectomy Probe
• 20380650004783: 25+ UNITY TOTALPLUS Posterior Pack, UES HyperVit 30K, WA
• 20380650004684: 27GA Infusion Cannula (includes TMD) – for use with 4mm/6 mm ES
• 10380650003345: 27+ UNITY TOTALPLUS Posterior Pack, UES HyperVit 30K DS, WA DS
• 10380650003321: 25+ UNITY TOTALPLUS Posterior Pack, UES Short, UltraVit 10K Short, STD
• 10380650003468: UNITY Cataract FMS Pack, 45° Hybrid Tip with Nano Infusion Sleeves
• 10380650003451: UNITY Cataract FMS Pack, 30° Hybrid Tip with Nano Infusion Sleeves
• 00380650003447: UNITY Cataract FMS Pack, 45° Balanced Tip with Nano Infusion Sleeves
• 10380650003437: UNITY Cataract FMS Pack, 30° Balanced Tip with Nano Infusion Sleeves
• 10380650003383: UNITY Cataract FMS Pack, 45° Hybrid Tip with Micro Infusion Sleeves
• 10380650003376: UNITY Cataract FMS Pack, 30° Hybrid Tip with Micro Infusion Sleeves
• 10380650003369: UNITY Cataract FMS Pack, 45° Balanced Tip with Micro Infusion Sleeves
• 10380650003352: UNITY Cataract FMS Pack, 30° Balanced Tip with Micro Infusion Sleeves
• 10380650003239: UNITY Cataract FMS Pack, Tipless with Nano Infusion Sleeves
• 10380650003222: UNITY Cataract FMS Pack, Tipless with Ultra Infusion Sleeves
• 10380650003215: UNITY Cataract FMS Pack, Tipless with Micro Infusion Sleeves
• 10380650003208: UNITY Cataract FMS Pack, Basic
• 10380657531773: 27+™ UltraVit™ 10K Probe
• 10380657531742: 23GA UltraVit™ 10K Probe
• 10380650008227: 27+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K DS, Wide Angle DS, Ultra,
• 10380650008210: 27+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K DS, Wide Angle DS, Ultra,
• 10380650008203: 27+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K DS, Straight DS, Ultra, T
• 10380650008197: 27+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K DS, Straight DS, Ultra, 4
• 10380650008180: 27+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K DS, Straight DS, Ultra, 3
• 10380650008135: 25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K, Wide Angle, Ultra, 45°
• 10380650008128: 25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K, Wide Angle, Ultra, 30°
• 10380650008081: 25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K, Straight, Ultra, Tipless
• 10380650008074: 25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K, Straight, Ultra, 45° Ba
• 10380650008067: 25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K, Straight, Ultra, 30° Ba
• 10380650008050: 25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K, Straight, Nano, Tipless
• 10380650007947: 27+ UNITY TOTALPLUS™ Posterior Pack, CVS ES HyperVit 30K DS, Wide Angle DS
• 10380650007923: 27+ UNITY TOTALPLUS™ Posterior Pack, CVS ES HyperVit 30K DS, Straight DS
• 20380650005193: 27+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K DS, Straight DS, Ultra, 45°
• 20380650005186: 27+ UNITY TOTALPLUS™ Combined Procedure Pack, UES HyperVit™ 30K DS, Straight DS, Ultra, 30°