Footswitch APYX-1253B

GUDID 00607151050191

Footswitch Monopolar

APYX MEDICAL CORPORATION

Electrosurgical system Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical

• Primary Device ID: 00607151050191
• NIH Device Record Key: 48bde69d-b9ef-497f-9995-4fe59f1e54c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Footswitch
• Version Model Number: APYX-1253B
• Catalog Number: APYX-1253B
• Company DUNS: 101223287
• Company Name: APYX MEDICAL CORPORATION
• 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	00607151050191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001955

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: 2020-03-31
• Device Publish Date: 2020-03-23

On-Brand Devices [Footswitch]

• 00607151050207: Footswitch Bipolar
• 00607151050191: Footswitch Monopolar