Apex Connect

GUDID 08809455601976

Apex Connect Main Body

META SYSTEMS CO., LTD.

Endodontic apex locator

• Primary Device ID: 08809455601976
• NIH Device Record Key: 74ee9e4d-a628-46d1-9b21-4355bf5681eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apex Connect
• Version Model Number: 815-1818
• Company DUNS: 687503532
• Company Name: META SYSTEMS CO., 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	08809455601976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210789

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-24
• Device Publish Date: 2022-11-16

On-Brand Devices [Apex Connect]

• 08809455602027: Apex Connect File Holder B
• 08809455602010: Apex Connect File Holder A
• 08809455602003: Apex Connect File Holder Adapter
• 08809455601990: Apex Connect Lip Hook
• 08809455601983: Apex Connect Probe Cord
• 08809455601976: Apex Connect Main Body
• 08809455601969: Apex Connect Kit - US
• 08809455601419: Apex Connect Kit - EU
• 08809455602768: Apex Connect Battery Pack - US