OPMI LUMERA 300

GUDID 06977585090013

No description

Carl Zeiss Meditec (Suzhou) Co., Ltd.

Ophthalmic surgical microscope

• Primary Device ID: 06977585090013
• NIH Device Record Key: 9466f68a-7368-402b-85cc-26390b209b3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPMI LUMERA 300
• Version Model Number: 6137
• Company DUNS: 631835173
• Company Name: Carl Zeiss Meditec (Suzhou) Co., Ltd.
• 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	06977585090013 [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: 2025-04-03
• Device Publish Date: 2025-03-26

Devices Manufactured by Carl Zeiss Meditec (Suzhou) Co., Ltd.

• 06977585090013 - OPMI LUMERA 300: 2025-04-03No description
• 06977585090013 - OPMI LUMERA 300: 2025-04-03 No description
• 06977585090051 - EXTARO 300: 2025-04-03
• 06977585090099 - EXTARO 300: 2025-04-03 No device description
• 06977585090129 - EXTARO 300: 2025-04-03 No device description
• 06977585090136 - EXTARO 300: 2025-04-03 No device description
• 06977585090143 - Fluorescence Mode: 2025-04-03