357 micron laser fiber 11949

GUDID 00810077631454

357-micron laser fiber, single use, sterile

OPTICAL INTEGRITY INC

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

• Primary Device ID: 00810077631454
• NIH Device Record Key: 2a22acd7-ab46-4efe-944b-d5f54b34ba97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 357 micron laser fiber
• Version Model Number: 11949
• Catalog Number: 11949
• 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: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com
• Phone: 8502335512
• Email: contact@opticalintegrity.com

Device Dimensions

• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer
• Outer Diameter: 357 Micrometer

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810077631454 [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: 2025-05-08
• Device Publish Date: 2025-04-30

Devices Manufactured by OPTICAL INTEGRITY INC

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• 00810077631454 - 357 micron laser fiber: 2025-05-08357-micron laser fiber, single use, sterile
• 00810077631454 - 357 micron laser fiber: 2025-05-08 357-micron laser fiber, single use, sterile
• 00810077631447 - Stripper Scribe Tool: 2025-04-21
• 00810077631430 - 200 micron Excalibur DC laser fiber: 2025-03-10 200-micron Excalibur DC Laser fiber
• 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