LithoWise

GUDID 00861062000328

365 micrometer laser fiber

FIBER OPTIC FABRICATIONS, INC.

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

• Primary Device ID: 00861062000328
• NIH Device Record Key: bd717bd7-bc94-4d0d-b259-2c4c94e4aac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LithoWise
• Version Model Number: LW-0002
• Company DUNS: 879359610
• Company Name: FIBER OPTIC FABRICATIONS, 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

Device Dimensions

• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer
• Outer Diameter: 365 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861062000328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120810

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

[00861062000328]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-12

On-Brand Devices [LithoWise]

• 00861062000342: 940 micrometer laser fiber
• 00861062000335: 550 micrometer laser fiber
• 00861062000328: 365 micrometer laser fiber
• 00861062000311: 272 micrometer laser fiber
• 00861062000359: 400 micrometer laser fiber