Optical Integrity Laser Fiber

GUDID B145109260

550 micrometer laser fiber, 4m length

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145109260
• NIH Device Record Key: 4d7a7abd-fba5-4e39-8b4c-d3c2a0009c13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optical Integrity Laser Fiber
• Version Model Number: 10926
• Company DUNS: 024050887
• Company Name: OPTICAL INTEGRITY INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: +1(850)233-5512
• Email: customercare@opticalintegrity.
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 550 Micrometer

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B145109260 [Primary]
HIBCC	B145109261 [Package]; Package: box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022338

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

[B145109260]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-28

On-Brand Devices [Optical Integrity Laser Fiber]

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• B145P001210000: 1000 micrometer laser fiber
• B145P00120550R0: 550 micrometer laser fiber reusable
• B145P001205500: 550 micrometer laser fiber
• B145P00120365R0: 365 micrometer laser fiber reusable
• B145P001203650: 365 micrometer laser fiber
• B145114961: 550 micrometer laser fiber with extension sleeve, reusable, nonsterile
• B145114141: 550 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
• B145114121: 365 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
• B145114101: 272 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
• B145112131: 1000 micrometer laser fiber with SMA extension sleeve
• B145109260: 550 micrometer laser fiber, 4m length
• B145108450: 1000 micrometer laser fiber, Trimedyne compatible
• B145108440: 550 micrometer laser fiber, Trimedyne compatible
• B145108430: 365 micrometer laser fiber, Trimedyne compatible
• B145107410: 550 micrometer laser fiber with extension sleeve, reusable
• B145107390: 365 micrometer laser fiber with extension sleeve, reusable
• B145106780: 600 micrometer reduced buffer with SMA 905 Connector, reusable
• B145106740: 365 micrometer Laser fiber, 4m length
• B145106620: 400 micrometer Laser fiber
• B145106280: 550 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
• B145106270: 365 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
• B145105920: 550 micrometer laser fiber with extension sleeve
• B145105480: 365 micrometer laser fiber with extension sleeve
• B145104870: 600 micrometer laser fiber without boot
• B145104430: 600 micrometer laser fiber with SMA 905 Connector
• B145103910: 1000 micrometer laser fiber reusable
• B145103900: 550 micrometer laser fiber reusable
• B145103890: 365 micrometer laser fiber reusable
• B145102390: 1000 micrometer laser fiber
• B145102380: 550 micrometer laser fiber
• B145102370: 365 micrometer laser fiber
• B145101530: 600 micrometer laser fiber without sleeve
• B145101510: 600 micrometer laser fiber without sleeve reusable