Q-Lase™ Side-Fire Fiber with Rotating Tip

GUDID B145113350

Q-Lase Side Fire Fiber with Rotating Tip

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145113350
• NIH Device Record Key: 7d077b09-276e-4fa0-933d-891cfbebe4ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Lase™ Side-Fire Fiber with Rotating Tip
• Version Model Number: 11335
• 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: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 800 Micrometer

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B145113350 [Primary]
HIBCC	B145113351 [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

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

Ethylene Oxide

[B145113350]

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

Devices Manufactured by OPTICAL INTEGRITY INC

• 00810077630969 - SmartScope: 2024-04-01 272 MICROMETER LASER FIBER, SINGLE USE, STERILE
• 00810077630976 - SmartScope: 2024-04-01 365 MICROMETER LASER FIBER, SINFGLE USE, STERILE
• 00810077630983 - SmartScope: 2024-04-01 550 MICROMETER LASER FIBER, SINGLE USE, STERILE
• 00810077630990 - SmartScope: 2024-04-01 1000 MICROMETER LASER FIBER, SINGLE USE, STERILE
• 00810077631348 - SmartScope: 2024-04-01 200 MICROMETER LASER FIBER, SINGLE USE, DISPOSABLE
• 00810077635711 - 200 TRUE ForTec Thulium TFL Laser Fiber: 2021-07-14 200 TRUE ForTec Thulium TFL Laser Fiber
• 00810077635728 - 272 ForTec Thulium TFL Laser Fiber: 2021-07-14 272 ForTec Thulium TFL Laser Fiber
• 00810077635735 - 365 ForTec Thulium TFL Laser Fiber: 2021-07-14 365 ForTec Thulium TFL Laser Fiber