ULITE PHACO HANDPIECE

GUDID 04049539100184

This active reusable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.

Carl Zeiss Meditec AG

Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece

• Primary Device ID: 04049539100184
• NIH Device Record Key: 75b0649c-c6d6-467e-b0c4-c70895e76997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULITE PHACO HANDPIECE
• Version Model Number: 303060-0001-000
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• 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	04049539100184 [Primary]

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

[04049539100184]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-03
• Device Publish Date: 2022-04-25

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• 04049471100167 - Treatment Pack (Type KP): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100136 - Treatment Pack (Size S): 2024-02-16 single use accessory for ZEISS femtosecond lasers
• 04049539101341 - EyeMag Smart: 2023-11-16
• 04049539101358 - EyeMag Pro S: 2023-11-16
• 04049539101365 - EyeMag Pro F: 2023-11-16
• 04049539064103 - PENTERO® 800 S: 2023-09-19