Eigr™ Waveguide CEW1NF

GUDID 00816728020059

The Eigr Waveguide, Narrow/Flat, LC is intended to provide surgical site illumination from a high intensity light source.

INVUITY, INC.

Surgical instrument fibreoptic light

• Primary Device ID: 00816728020059
• NIH Device Record Key: cf9457e9-fe2f-4359-82ba-ce5f753a787b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eigr™ Waveguide
• Version Model Number: Narrow / Flat, LC
• Catalog Number: CEW1NF
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816728020059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090070

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

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

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

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