1000 Laser Fiber, Reusable 10391

GUDID 00810077630150

1000 Laser Fiber, Reusable

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00810077630150
• NIH Device Record Key: acc815b4-950e-40db-96c5-653958591aca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1000 Laser Fiber, Reusable
• Version Model Number: OI-1000R-FT-000-BIG-1
• Catalog Number: 10391
• Company DUNS: 024050887
• Company Name: OPTICAL INTEGRITY INC
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com
• Phone: 8502335512
• Email: purchasing@opticalintegrity.com

Device Dimensions

• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 Micrometer
• Outer Diameter: 1000 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810077630150 [Primary]

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: 2021-05-25
• Device Publish Date: 2021-05-17

Devices Manufactured by OPTICAL INTEGRITY INC

• 00810077631393 - 300 micron laser fiber (KTP) with ScopeGuardian sheath: 2024-10-02 300 micron laser fiber (KTP) with ScopeGuardian sheath, single use, sterile
• 00810077631362 - 300 micron laser fiber (KTP): 2024-09-16 300-micron laser fiber, single use disposable (KTP)
• 00810077631355 - 300 micron laser fiber (KTP): 2024-08-19 300 micron laser fiber, single use disposable (KTP)
• 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