OPMI® PENTERO® 900

GUDID 04049539066374

Carl Zeiss Meditec AG

Neurosurgical microscope

• Primary Device ID: 04049539066374
• NIH Device Record Key: a6010948-7280-4c1b-8b93-85efb27b5f89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPMI® PENTERO® 900
• Version Model Number: 302582-9902-000
• 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	04049539066374 [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

• 04049539105509 - INTRABEAM Spherical Sizer Set: 2025-06-30 The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therap
• 04049539105516 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105523 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105530 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105547 - INTRABEAM SMART Spherical Applicator (35 mm): 2025-05-22
• 04049539105554 - INTRABEAM SMART Spherical Applicator (35mm): 2025-05-22
• 04049539105561 - INTRABEAM SMART Spherical Applicator (40mm): 2025-05-22
• 04049539105578 - INTRABEAM SMART Spherical Applicator (45mm): 2025-05-22