CompuDent STA

GUDID 20618874000015

STA Instrument

TRICOR SYSTEMS, INC.

Dental computer assisted anaesthesia injection unit

• Primary Device ID: 20618874000015
• NIH Device Record Key: ebec6c7b-1fad-4d9c-8ea1-2e49d3b3e22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompuDent STA
• Version Model Number: STA-5110
• Company DUNS: 070164694
• Company Name: TRICOR SYSTEMS, INC.
• Device Count: 4
• DM Exempt: true
• 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	10618874000011 [Unit of Use]
GS1	20618874000015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061904

FDA Product Code

• EJI: Syringe, Cartridge

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: 2018-01-26

On-Brand Devices [CompuDent STA]

• 00618874000011: STA Instrument
• 20618874000015: STA Instrument