Treatment Pack (Size M)

GUDID 04049471100143

single use accessory for ZEISS femtosecond lasers

Carl Zeiss Meditec AG

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 04049471100143
• NIH Device Record Key: 6526bb7e-c512-4e2f-818a-2181cbe36877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Treatment Pack (Size M)
• Version Model Number: 1014
• 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	04049471100143 [Unit of Use]
GS1	04049471110142 [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: 2024-02-19
• Device Publish Date: 2024-02-09

Devices Manufactured by Carl Zeiss Meditec AG

• 04049471095074 - MEL 90: 2024-12-23 The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue ac
• 04049471095111 - VISUMAX: 2024-12-23 The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in th
• 04049539106704 - Single-use lenses for RESIGHT, MACULA LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539106735 - Single-use lenses for RESIGHT, WIDE-ANGLE LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539106766 - Single-use lenses for RESIGHT, ULTRA WIDE-ANGLE LENS: 2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
• 04049539064097 - KINEVO 900 S: 2024-10-15
• 04049539070159 - BLUE 400: 2024-10-15 accessory for surgical microscopes
• 04049539070166 - YELLOW 560: 2024-10-15 accessory for surgical microscopes