Treatment Pack (Size S)

GUDID 04049471100136

single use accessory for ZEISS femtosecond lasers

Carl Zeiss Meditec AG

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 04049471100136
• NIH Device Record Key: da600604-4862-415d-bac7-90e835d5b817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Treatment Pack (Size S)
• Version Model Number: 1013
• Company DUNS: 314594680
• Company Name: Carl Zeiss Meditec AG
• Device Count: 10
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471100136 [Unit of Use]
GS1	04049471110135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150040

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [Treatment Pack (Size S)]

• 04049471110043: Single use patient interface for the VisuMax laser keratome
• 04049471100136: single use accessory for ZEISS femtosecond lasers