SmartScope 11920

GUDID 00810077630969

272 MICROMETER LASER FIBER, SINGLE USE, STERILE

OPTICAL INTEGRITY INC

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

• Primary Device ID: 00810077630969
• NIH Device Record Key: 150de1e7-9e73-46e9-b263-83acc89cea31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartScope
• Version Model Number: SU-200-RT
• Catalog Number: 11920
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810077630969 [Package]; Contains: 00810077631294; Package: CARTON [5 Units]; In Commercial Distribution
GS1	00810077631294 [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: 2024-04-01
• Device Publish Date: 2024-03-22

On-Brand Devices [SmartScope]

• 00810077631348: 200 MICROMETER LASER FIBER, SINGLE USE, DISPOSABLE
• 00810077630990: 1000 MICROMETER LASER FIBER, SINGLE USE, STERILE
• 00810077630983: 550 MICROMETER LASER FIBER, SINGLE USE, STERILE
• 00810077630976: 365 MICROMETER LASER FIBER, SINFGLE USE, STERILE
• 00810077630969: 272 MICROMETER LASER FIBER, SINGLE USE, STERILE