OPMI® PENTERO® 800

GUDID 04049539066411

Carl Zeiss Meditec AG

Neurosurgical microscope

• Primary Device ID: 04049539066411
• NIH Device Record Key: 27102140-0731-4e77-a726-4e3968aa5b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPMI® PENTERO® 800
• Version Model Number: 302582-9903-000
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04049539066411 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• 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