UNITY 8065000341

GUDID 10380650003413

UNITY Cataract FMS Pack, 30° Hybrid Tip with Ultra Infusion Sleeves

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10380650003413
• NIH Device Record Key: d1c2acbb-c2e4-4784-89ba-e8cb2a380df3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNITY
• Version Model Number: 00380650003416
• Catalog Number: 8065000341
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380650003416 [Primary]
GS1	10380650003413 [Package]; Contains: 00380650003416; Package: Box [6 Units]; In Commercial Distribution

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

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