CellFX CH03

GUDID 00850003231419

CellFX Handpiece

Pulse Biosciences, Inc.

Electrosurgical system

• Primary Device ID: 00850003231419
• NIH Device Record Key: 15cc32e2-dee0-4a9a-95ba-841573e20f4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CellFX
• Version Model Number: FG2250-01
• Catalog Number: CH03
• Company DUNS: 080114073
• Company Name: Pulse Biosciences, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003231419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203299

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

On-Brand Devices [CellFX]

• 10850003231669: CellFX Treatment Tip – 5 x 5mm [2mm]
• 10850003231638: CellFX Treatment Tip – 2.5 x 2.5mm [2mm]
• 10850003231607: CellFX Treatment Tip – 1.5 x 1.5mm [2mm]
• 00850003231419: CellFX Handpiece
• 00850003231389: CellFX Console
• 10850003231652: CellFX Treatment Tip – 5 x 5mm [1mm]
• 10850003231621: CellFX Treatment Tip – 2.5 x 2.5mm [1mm]
• 10850003231591: CellFX Treatment Tip – 1.5 x 1.5mm [1mm]