PENTERO® 800 S

GUDID 04049539064103

Carl Zeiss Meditec AG

General-purpose surgical microscope

• Primary Device ID: 04049539064103
• NIH Device Record Key: 273c3cef-c0b6-4011-b150-c11e07e56ba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENTERO® 800 S
• Version Model Number: 6410
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04049539064103 [Primary]

FDA Product Code

• FSO: Microscope, Surgical, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-19
• Device Publish Date: 2023-09-11

Devices Manufactured by Carl Zeiss Meditec AG

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• 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
• 04049539069214 - CALLISTO eye Panel PC: 2024-06-14
• 04049539070302 - CALLISTO eye Software: 2024-06-14
• 04049539066497 - ARTEVO 750/850: 2024-05-22 ARTEVO 750/850 is a surgical microscope intended for the magnification of the surgical area and for the visualization in surgica
• 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