QLASE Adjustable Stand-Off Catheter 11515

GUDID 00810077630488

QLASE Adjustable Stand-Off Catheter

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 00810077630488
• NIH Device Record Key: 487e00f8-0467-4c4c-ba62-53cb89b535cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QLASE Adjustable Stand-Off Catheter
• Version Model Number: OI-0750S-SF-CO0-LEX-1
• Catalog Number: 11515
• Company DUNS: 024050887
• Company Name: OPTICAL INTEGRITY INC
• Device Count: 1
• DM Exempt: false
• 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: false
• 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: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com
• Phone: 18502335512
• Email: purchasing@opticalintegrity.com

Device Dimensions

• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 Micrometer
• Outer Diameter: 750 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
GS1	00810077630488 [Primary]
GS1	00810077635704 [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: 2021-05-27
• Device Publish Date: 2021-05-19

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