300 Flex-G Laser Fiber with Sheath for Calculase 11098

GUDID 00810077633380

300 Flex-G Laser Fiber with Sheath for Calculase

OPTICAL INTEGRITY INC

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

• Primary Device ID: 00810077633380
• NIH Device Record Key: c145ba77-9445-46ba-b346-903155f9c5bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 300 Flex-G Laser Fiber with Sheath for Calculase
• Version Model Number: KS-0300S-FT-SC0-LEX-1
• Catalog Number: 11098
• 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: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 Micrometer
• Outer Diameter: 300 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	00810077630389 [Primary]
GS1	00810077633380 [Package]; Contains: 00810077630389; Package: Carton [3 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: 2021-05-26
• Device Publish Date: 2021-05-18

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• 00810077630990 - SmartScope: 2024-04-01 1000 MICROMETER LASER FIBER, SINGLE USE, STERILE
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• 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