FlexGuard Fiber with Sheath

GUDID B14527750272U13FS1

272 micrometer FlexGuard Fiber with Sheath

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B14527750272U13FS1
• NIH Device Record Key: 084af180-9188-4520-8b86-6b58e4af9d07
• Commercial Distribution Discontinuation: 2017-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FlexGuard Fiber with Sheath
• Version Model Number: 27750272U1FS
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com
• Phone: +1(850)233-5512
• Email: customercare@opticalintegrity.com

Device Dimensions

• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0
• Outer Diameter: 272 Micrometer
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 37 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14527750272U13FS1 [Package]; Contains: B14527750272U1FS0; Package: box [3 Units]; Discontinued: 2017-03-28; Not in Commercial Distribution
HIBCC	B14527750272U1FS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100194

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

[B14527750272U13FS1]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-28

On-Brand Devices [FlexGuard Fiber with Sheath]

• B14527750300U13FS1: 300 micrometer FlexGuard Fiber with Sheath
• B14527750272U13FS1: 272 micrometer FlexGuard Fiber with Sheath
• B14527750200U13FS1: 200 micrometer FlexGuard Fiber with Sheath