RESISTICK™ ES57T

GUDID 10607151005778

RESISTICK™LL COATED STANDARD 3MM BALL ELECTRODE 2'' (5.08CM) RESISTICK™II COATED EXTENDED MODIFIED NEEDLE ELECTRODE 4'' (10.16CM)

BOVIE MEDICAL CORPORATION

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 10607151005778
• NIH Device Record Key: cdf3450b-cd91-48fd-b753-0715aa435f9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESISTICK™
• Version Model Number: ES57T
• Catalog Number: ES57T
• Company DUNS: 079940465
• Company Name: BOVIE 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607151005771 [Primary]
GS1	10607151005778 [Package]; Contains: 00607151005771; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093025

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-07

On-Brand Devices [RESISTICK™]

• 10607151005808: RESISTICK™LL COATED STANDARD 3MM BALL ELECTRODE 2'' (5.08CM)
• 10607151005778: RESISTICK™LL COATED STANDARD 3MM BALL ELECTRODE 2'' (5.08CM) RESISTICK™II COATED EXTENDED MO
• 10607151005754: RESISTICK™ LL COATED EXTENDED MODIFIED BLADE ELECTRODE 2.75'' (6.985CM)
• 10607151005747: RESISTICK™LL COATED MODIFIED BLADE ELECTRODE 2.75'' (6.985CM)
• 10607151005723: RESISTICK™II COATED MODIFIED BLADE ELECTRODE 2.5'' (6.35CM) RESISTICK™II COATED EXTENDED MOD
• 10607151005679: RESISTICK™LL COATED EXTENDED MODIFIED NEEDLE ELECTRODE 6'' (15.24CM)