J-PLASMA® PRECISE™ BVX-450N

GUDID 10607151010192

J-PLASMA® PRECISE™ HANDPIECE NEEDLE TIP, 5MM-Ø 45CM-LENGTH, PISTOL GRIP

BOVIE MEDICAL CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 10607151010192
• NIH Device Record Key: 35aab0ef-51f0-4b9e-8ed3-99fc1a461dcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J-PLASMA® PRECISE™
• Version Model Number: BVX-450N
• Catalog Number: BVX-450N
• 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	00607151010195 [Primary]
GS1	10607151010192 [Package]; Contains: 00607151010195; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151325

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® PRECISE™]

• 00607151011987: J-PLASMA® PRECISE™ FLEX, 500mm
• 10607151011922: J-PLASMA® PRECISE™ Open, 150mm
• 10607151011915: J-PLASMA® PRECISE™ Open, 44mm
• 10607151011878: J-PLASMA® PRECISE™ Open, 150mm
• 10607151011861: J-PLASMA® PRECISE™ Open, 44mm
• 10607151010758: J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH NEEDLE TIP, 45cm
• 10607151010741: J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH BLADE, 45cm
• 10607151010734: J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH NEEDLE TIP, 33cm
• 10607151010727: J-PLASMA® PRECISE™ 360 LAPAROSCOPIC HAND DEVICE WITH BLADE, 33cm
• 10607151010192: J-PLASMA® PRECISE™ HANDPIECE NEEDLE TIP, 5MM-Ø 45CM-LENGTH, PISTOL GRIP
• 10607151010185: J-PLASMA® PRECISE™ HANDPIECE NEEDLE TIP, 5MM-Ø 33CM-LENGTH, PISTOL GRIP
• 10607151010178: J-PLASMA® PRECISE™ HANDPIECE NEEDLE TIP, 5MM-Ø 150CM-LENGTH, PISTOL GRIP
• 10607151010161: J-PLASMA® PRECISE™ HANDPIECE BLADE TIP, 5MM-Ø 45CM-LENGTH, PISTOL GRIP
• 10607151010154: J-PLASMA® PRECISE™ HANDPIECE BLADE TIP, 5MM-Ø 33CM-LENGTH, PISTOL GRIP
• 10607151010147: J-PLASMA® PRECISE™ HANDPIECE BLADE TIP, 5MM-Ø 150CM-LENGTH, PISTOL GRIP