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

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• 04049539066503 - INTRABEAM SMART Stand: 2025-04-09 The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-
• 04049539066435 - TIVATO® 700: 2025-01-30
• 04049539106018 - SMARTDRAPE: 2025-01-30
• 04049539106070 - INTRABEAM SMARTDRAPE: 2025-01-30
• 04049539106094 - SMARTDRAPE: 2025-01-30
• 04049539106889 - EyeMag Smart TTL: 2025-01-30
• 04049539106896 - EyeMag Classic: 2025-01-30