MAXX LUXX LED

GUDID 00815871021579

DRE TRIO MAXX LUXX W/HD CAMERA

Avante

Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount Medical monitor/light mount

• Primary Device ID: 00815871021579
• NIH Device Record Key: 490ed4d3-22c5-4d20-898a-453d56950e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXX LUXX LED
• Version Model Number: DRE SD2D2P4
• Company DUNS: 178440426
• Company Name: Avante
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871021579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100388

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-19
• Device Publish Date: 2016-09-23

On-Brand Devices [MAXX LUXX LED]

• 00815871022125: DRE DUAL MAXX LUXX, DUAL MONITOR ARM
• 00815871022118: DRE DUAL MAXX LUXX LED, HD CAM & MONITOR ARM
• 00815871022101: DRE DUAL MAXX LUXX LED, HD CAM & MONITOR ARM
• 00815871022095: DRE SINGLE MAXX LUXX, DUAL MONITOR ARM
• 00815871022088: DRE TRIO MAXX LUX LED
• 00815871022071: DRE DUAL MAXX LUXX LED, VIDEO READY
• 00815871022064: DRE TRIO MAXX LUXX LED W/MON
• 00815871022057: DRE TRIO MAXX LUXX W/HD CAMERA
• 00815871022040: DRE TRIO MAXX LUXX W/HD CAMERA
• 00815871022033: DRE DUAL MAXX LUXX LED
• 00815871022026: DRE MAXX LUXX LED, VIDEO READY
• 00815871022019: DRE DUAL MAXX LUXX LED W/MON
• 00815871022002: DRE DUAL MAXX LUXX LED W/HD
• 00815871021999: DRE DUAL MAXX LUXX LED W/HD
• 00815871021982: DRE SINGLE MAXX LUXX LED
• 00815871021562: DRE TRIO MAXX LUXX W/HD CAMERA
• 00815871021555: DRE DUAL MAXX LUXX LED
• 00815871021548: DRE MAXX LUXX LED, VIDEO READY
• 00815871021531: DRE DUAL MAXX LUXX LED W/MON
• 00815871021524: DRE DUAL MAXX LUXX LED W/HD
• 00815871021517: AVANTE DUAL MAXX LUXX LED W/HD
• 00815871021500: DRE SINGLE MAXX LUXX LED
• 00815871021883: DRE DUAL MAXX LUXX, DUAL MONITOR ARM
• 00815871021630: DRE DUAL MAXX LUXX LED, HD CAM & MONITOR ARM
• 00815871021623: DRE DUAL MAXX LUXX LED, HD CAM & MONITOR ARM
• 00815871021616: DRE SINGLE MAXX LUXX, DUAL MONITOR ARM
• 00815871021609: DRE TRIO MAXX LUX LED
• 00815871021593: DRE DUAL MAXX LUXX LED, VIDEO READY
• 00815871021586: DRE TRIO MAXX LUXX LED W/MON
• 00815871021579: DRE TRIO MAXX LUXX W/HD CAMERA