VisuMax

GUDID 04049471095036

The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatm

Carl Zeiss Meditec AG

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 04049471095036
• NIH Device Record Key: 75281e57-f96d-4de8-a7ba-6cb088f340b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisuMax
• Version Model Number: VisuMax
• Company DUNS: 314594680
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Local altitude max. 2000 m
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471095036 [Primary]

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-23
• Device Publish Date: 2016-09-23

Devices Manufactured by Carl Zeiss Meditec AG

• 04049471100143 - Treatment Pack (Size M): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100150 - Treatment Pack (Size L): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 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