Sonus Nose Cone 806-1105

GUDID 00636266958337

White plastic nose cone for scaling handpiece

ENGLER ENGINEERING CORPORATION

Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 00636266958337
• NIH Device Record Key: 74fe21f6-c18a-45b6-bc2f-1a9011704167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonus Nose Cone
• Version Model Number: 806-1105
• Catalog Number: 806-1105
• Company DUNS: 002965168
• Company Name: ENGLER ENGINEERING CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00636266958337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811396

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[00636266958337]

Liquid Chemical

[00636266958337]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-07-09

On-Brand Devices [Sonus Nose Cone]

• 00636266958337: White plastic nose cone for scaling handpiece
• 00862872000348: White plastic nose cone which slips over tip and provides means of tightening tip to insert. (Fo