Optomic

GUDID 08436041580034

OPTOMIC ESPAÑA SA

Dental surgical microscope

• Primary Device ID: 08436041580034
• NIH Device Record Key: 27e168c9-8953-431d-91e7-9ae361f9aa54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optomic
• Version Model Number: OP-DENT5 Microscope (240)
• Company DUNS: 564165678
• Company Name: OPTOMIC ESPAÑA SA
• 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: false
• 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	08436041580034 [Primary]

FDA Product Code

• EPT: Microscope, Surgical

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: 2024-07-25
• Device Publish Date: 2024-07-17

On-Brand Devices [Optomic]

• 08436041581352: OP-12 Microscope
• 08436041580294: OP-2000 HD Camera
• 08436041580270: OP-714 Camera
• 08436041580263: Strobolux III LED + HD Stroboscope
• 08436041580256: Strobolux III LED Stroboscope
• 08436041580164: OP-LS5 Portable LED Light Source
• 08436041580157: Fibrolux LED HP Duo Light Source
• 08436041580140: Fibrolux LED HP Light Source (Amber)
• 08436041580133: Fibrolux LED HP Light Source
• 08436041580072: OP-C16 Microscope (240)
• 08436041580065: OP-C16 Microscope
• 08436041580041: OP-DENT5 Microscope (45)
• 08436041580034: OP-DENT5 Microscope (240)
• 08436041580027: OP-DENT Microscope (45)
• 08436041580010: OP-DENT Microscope (240)