Tuxedo 6100

GUDID 00754020100065

LED Dental Inc

Dental digital imaging sensor, intraoral

• Primary Device ID: 00754020100065
• NIH Device Record Key: c90fd656-24f0-4193-adfc-900b43435e48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuxedo
• Version Model Number: Size 1
• Catalog Number: 6100
• Company DUNS: 243167546
• Company Name: LED Dental Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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	00754020100065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153710

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2016-09-24

On-Brand Devices [Tuxedo]

• 00754020100072: Size 2
• 00754020100065: Size 1
• 00754020100249: Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR
• 00754020100232: Tuxedo Intraoral Sensor Size 1 (6100A Replacement) PN 6100AR
• 00754020100225: Tuxedo Intraoral Sensor Size 2 (6101 Replacement) PN 6101R
• 00754020100218: Tuxedo Intraoral Sensor Size 1 (6100 Replacement)
• 07540201000247: Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR
• 07540201000230: Tuxedo Intraoral Sensor Size 1 (6100A Replacement) PN 6100AR
• 07540201000223: Tuxedo Intraoral Sensor Size 2 (6101 Replacement) PN 6101R
• 07540201000216: Tuxedo Intraoral Sensor Size 1 (6100 Replacement)
• 07540201000070: Size 2
• 07540201000063: Size 1