neoV BG16401

GUDID 07290016629071

neoV 1064nm Laser System, 12W, 650nm aiming beam, SMA

G.N.S NEOLASER LTD

General/multiple surgical diode laser system

• Primary Device ID: 07290016629071
• NIH Device Record Key: cf412e36-34d0-48cb-b1e2-74781e8f61db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoV
• Version Model Number: neoV1064
• Catalog Number: BG16401
• Company DUNS: 600476878
• Company Name: G.N.S NEOLASER LTD
• 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	07290016629071 [Primary]
GS1	07290016629200 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133006

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [neoV]

• 07290016629132: neoV 1470nm Laser System, 12W, 635nm aiming beam, SMA
• 07290016629125: neoV 1470nm Laser System, 12W, 635nm aiming beam, NC
• 07290016629118: neoV 1470nm Laser System, 12W, 650nm aiming beam, SMA
• 07290016629101: neoV 1470nm Laser System, 12W, 650nm aiming beam, NC
• 07290016629095: neoV 1064nm Laser System, 24W, 650nm aiming beam, SMA
• 07290016629088: neoV 1064nm Laser System, 24W, 650nm aiming beam, NC
• 07290016629071: neoV 1064nm Laser System, 12W, 650nm aiming beam, SMA
• 07290016629064: neoV 1064nm Laser System, 12W, 650nm aiming beam, NC
• 07290016629057: neoV 810nm Laser System, 28W, 650nm aiming beam, SMA
• 07290016629040: neoV 810nm Laser System, 28W, 650nm aiming beam, NC
• 07290016629170: neoV 980nm Laser System, 28W, 635nm aiming beam, SMA
• 07290016629026: neoV 980nm Laser System, 28W, 650nm aiming beam, SMA
• 07290016629019: neoV 980nm Laser System, 28W, 635nm aiming beam, NC
• 07290016629149: neoV 980nm Laser System, 28W, 650nm aiming beam, NC