Invuity® Fiber Optic Cable 110001

GUDID 00816728020219

The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to provide surgical site illumination from a high intensity light source.

INVUITY, INC.

Fibreoptic light cable

• Primary Device ID: 00816728020219
• NIH Device Record Key: 679625ca-a8c1-49f7-a798-cb478711c4e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invuity® Fiber Optic Cable
• Version Model Number: Bifurcated
• Catalog Number: 110001
• Company DUNS: 175697908
• Company Name: INVUITY, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com

Device Dimensions

• Length: 8 Feet
• Length: 8 Feet
• Length: 8 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816728020219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090070

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

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

[00816728020219]

Moist Heat or Steam Sterilization

[00816728020219]

Moist Heat or Steam Sterilization

[00816728020219]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-24
• Device Publish Date: 2016-09-22

On-Brand Devices [Invuity® Fiber Optic Cable]

• 00816728020226: The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr
• 00816728020219: The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr
• 00816728020202: The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr
• 00816728020196: The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr
• 00816728020189: The Invuity Single Fiber Optic Cable and Invuity Bifurcated Fiber Optic Cable are intended to pr