ScopeGuardian™ Sheath only

GUDID B145109201

Sheath for 300 micrometer ScopeSafe laser fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145109201
• NIH Device Record Key: 87358253-41fb-47d9-b26f-7b172591078d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScopeGuardian™ Sheath only
• Version Model Number: 10918
• 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: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 300 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	B145109180 [Primary]
HIBCC	B145109201 [Package]; Contains: B145109180; Package: box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100194

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

Ethylene Oxide

[B145109201]

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 [ScopeGuardian™ Sheath only]

• B14527750300UISHO1: Sheath for 300 micrometer ScopeSafe laser fiber
• B145109201: Sheath for 300 micrometer ScopeSafe laser fiber