PhotonBlade® PBPG1

GUDID 00816728020523

The PhotonBlade Breast Kit consists of (1) PhotonBlade packaged with a (1) PhotonGuide, Wide / Angled illuminator for the convenience of the user. The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units. The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.

INVUITY, INC.

Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00816728020523
• NIH Device Record Key: e07bd0c2-eec4-4459-b3c5-0822a6e5310e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhotonBlade®
• Version Model Number: PhotonBlade Breast Kit
• Catalog Number: PBPG1
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00816728020523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162053

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-24
• Device Publish Date: 2018-02-26

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