SmartScope laser fiber

GUDID B145116731

272 micrometer SmartScope laser fiber single use, sterile, round tip

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145116731
• NIH Device Record Key: 15f13336-cfc1-405e-aac3-e691cb4b09b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartScope laser fiber
• Version Model Number: 11553
• 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: 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

Device Dimensions

• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 Micrometer
• Outer Diameter: 272 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
HIBCC	B145115530 [Primary]
HIBCC	B145116731 [Package]; Contains: B145115530; 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: 2018-12-31
• Device Publish Date: 2018-11-28

On-Brand Devices [SmartScope laser fiber]

• B145116791: 1000 micrometer SmartScope laser fiber, signel use, sterile, round tip
• B145116771: 550 micrometer SmartScope laser fiber, single use, sterile, round tip
• B145116751: 365 micrometer SmartScope laser fiber, single use, sterile, round tip
• B145116731: 272 micrometer SmartScope laser fiber single use, sterile, round tip
• B145116711: 200 micrometer SmartScope laser fiber, single use, sterile, round tip