ScopeSafe™Laser Fiber

GUDID B145103791

200 micrometer ScopeSafe laser fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145103791
• NIH Device Record Key: f4d74697-7536-4fbd-863c-73f3945cf9bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScopeSafe™Laser Fiber
• Version Model Number: 10366
• 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: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 200 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	B145103660 [Primary]
HIBCC	B145103791 [Package]; Contains: B145103660; 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

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

Ethylene Oxide

[B145103791]

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: 2016-08-03

On-Brand Devices [ScopeSafe™Laser Fiber]

• B145P00120300SSR0: 300 micrometer ScopeSafe laser fiber reusable
• B145P00120300SS0: 300 micrometer ScopeSafe laser fiber
• B145P00120272SS0: 272 micrometer ScopeSafe laser fiber
• B145P00120200SS0: 200 micrometer ScopeSafe laser fiber
• B14527750940U131: 940 micrometer ScopeSafe laser fiber
• B14527750550U131: 550 micrometer ScopeSafe laser fiber
• B14527750365U131: 365 micrometer ScopeSafe laser fiber
• B14527750300U131: 300 micrometer ScopeSafe laser fiber
• B14527750272U131: 272 micrometer ScopeSafe laser fiber
• B14527750200U131: 200 micrometer ScopeSafe laser fiber
• B145112110: 200 micrometer ScopeSafe laser fiber with Sheath
• B145109660: 272 micrometer ScopeSafe laser fiber with 895mm length Sheath
• B145109041: 300 micrometer ScopeSafe laser fiber
• B145108500: 1000 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
• B145108490: 550 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
• B145108480: 365 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
• B145108470: 300 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
• B145108460: 272 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
• B145108420: 300 micrometer ScopeSafe laser fiber, Trimedyne compatible
• B145108410: 272 micrometer ScopeSafe laser fiber, Trimedyne compatible
• B145108400: 200 micrometer ScopeSafe laser fiber, Trimedyne compatible
• B145107280: 272 micrometer ScopeSafe laser fiber with extension sleeve, reusable
• B145107190: 300 micrometer ScopeSafe laser fiber with Sheath
• B145106830: 272 micrometer ScopeSafe laser fiber with Sheath
• B145106810: 200 micrometer ScopeSafe laser fiber with Sheath
• B145106450: 200 micrometer ScopeSafe laser fiber, 4m length
• B145106260: 300 micrometer ScopeSafe laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
• B145106250: 272 micrometer ScopeSafe laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
• B145105910: 300 micrometer ScopeSafe laser fiber with extension sleeve
• B145105600: 272 micrometer ScopeSafe laser fiber with extension sleeve
• B145103880: 300 micrometer ScopeSafe laser fiber reusable
• B145103831: 940 micrometer ScopeSafe laser fiber
• B145103821: 550 micrometer ScopeSafe laser fiber
• B145103811: 365 micrometer ScopeSafe laser fiber
• B145103801: 272 micrometer ScopeSafe laser fiber
• B145103791: 200 micrometer ScopeSafe laser fiber
• B145102360: 200 micrometer ScopeSafe laser fiber
• B145102120: 300 micrometer ScopeSafe laser fiber
• B145102110: 272 micrometer ScopeSafe laser fiber