ScopeSafe laser fiber with Soft Tip Stand Off Jack

GUDID B145115310

200 micron ScopeSafe laser fiber with Stand Off Jacket, single use, sterile

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B145115310
• NIH Device Record Key: a8e63f79-911b-454f-8f4f-ecb997b26c7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScopeSafe laser fiber with Soft Tip Stand Off Jack
• Version Model Number: 11531
• Company DUNS: 024050887
• Company Name: OPTICAL INTEGRITY INC
• Device Count: 1
• DM Exempt: true
• 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: 850-233-5512
• Email: Customercare@opticalintegrity.
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com
• Phone: 850-233-5512
• Email: Customercare@opticalintegrity.com

Device Dimensions

• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 Micrometer
• Outer Diameter: 200 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
• 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	B145115310 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-16
• Device Publish Date: 2018-06-15

Devices Manufactured by OPTICAL INTEGRITY INC

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• 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