J-PLASMA® GS-018C

GUDID 10607151007819

J-PLASMA® HANDPIECE WITH CABLE OPEN - 18MM

BOVIE MEDICAL CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 10607151007819
• NIH Device Record Key: 5677c091-dc72-49a2-a946-dd9a50921aff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J-PLASMA®
• Version Model Number: GS-018C
• Catalog Number: GS-018C
• 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: true
• 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	00607151007812 [Primary]
GS1	10607151007819 [Package]; Contains: 00607151007812; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112233

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: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-21

On-Brand Devices [J-PLASMA® ]

• 10607151009455: J-PLASMA® HANDPIECE BLADE TIP, 5MM-Ø 27CM-LENGTH, PISTOL GRIP
• 10607151007819: J-PLASMA® HANDPIECE WITH CABLE OPEN - 18MM
• 10607151007604: J-PLASMA® HANDPIECE WITH CABLE OPEN - 27mm