PhotonGuide 104001

GUDID 00816728020097

The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.

INVUITY, INC.

Surgical instrument fibreoptic light

• Primary Device ID: 00816728020097
• NIH Device Record Key: 312d5237-6c21-40f9-a255-bdbb5a5c919e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhotonGuide
• Version Model Number: Narrow / Angled
• Catalog Number: 104001
• Company DUNS: 175697908
• Company Name: INVUITY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00816728020097 [Primary]

FDA Product Code

• FSZ: Light, Surgical, Carrier

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-24
• Device Publish Date: 2016-09-22

On-Brand Devices [PhotonGuide]

• 00816728020097: The PhotonGuide is intended to provide surgical site illumination from a high intensity light so
• 00816728020080: The PhotonGuide is intended to provide surgical site illumination from a high intensity light so
• 00816728020073: The PhotonGuide is intended to provide surgical site illumination from a high intensity light so
• 00816728020066: The PhotonGuide is intended to provide surgical site illumination from a high intensity light so