400 micrometer fiber KTP-400

GUDID B145116380

400 micrometer fiber compatible for use with AURA XP laser

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145116380
• NIH Device Record Key: 875ad070-c9d9-4a82-9614-a58a231ec286
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 400 micrometer fiber
• Version Model Number: 11638
• Catalog Number: KTP-400
• Company DUNS: 024050887
• Company Name: OPTICAL INTEGRITY INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8502335512
• Email: customercare@opticalintegrity.
• Phone: 8502335512
• Email: customercare@opticalintegrity.
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com
• Phone: 8502335512
• Email: customercare@opticalintegrity.com

Device Dimensions

• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 Micrometer
• Outer Diameter: 400 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	B145116380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022338

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-08-03
• Device Publish Date: 2018-06-28

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