365 ScopeSafe Laser Fiber 10237

GUDID 00810077633045

365 ScopeSafe Laser Fiber, Single Use

OPTICAL INTEGRITY INC

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

• Primary Device ID: 00810077633045
• NIH Device Record Key: 73477587-7b87-4e1d-baef-28b3f9c80455
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 365 ScopeSafe Laser Fiber
• Version Model Number: OI-0365S-FT-000-BIG-1
• Catalog Number: 10237
• 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

Device Dimensions

• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 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	00810077630044 [Primary]
GS1	00810077633045 [Package]; Contains: 00810077630044; 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: 2021-04-21
• Device Publish Date: 2021-04-13

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