SU-200-TRUE

GUDID B145117040

200 micron laser fiber, single use, sterile

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145117040
• NIH Device Record Key: b828ed0d-5dd3-41c0-a490-d604a9af528d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SU-200-TRUE
• Version Model Number: 11704
• Company DUNS: 024050887
• Company Name: OPTICAL INTEGRITY INC
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 850-233-5512
• Email: customercare@opticalintegrity.
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: customercare@opticalintegrity.com

Device Dimensions

• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B145117040 [Primary]
HIBCC	B145117371 [Package]; Package: carton [5 Units]; In Commercial Distribution

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-31
• Device Publish Date: 2018-11-29

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