NovApex

GUDID 07290114350006

NovApex N-31 Apex Locator

FORUM ENGINEERING TECHNOLOGIES (96) LTD.

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• Primary Device ID: 07290114350006
• NIH Device Record Key: 4f2b2bfd-1769-4698-a150-fb6799341571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovApex
• Version Model Number: N-31
• Company DUNS: 532219235
• Company Name: FORUM ENGINEERING TECHNOLOGIES (96) 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	07290114350006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121206

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

[07290114350006]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-24

Devices Manufactured by FORUM ENGINEERING TECHNOLOGIES (96) LTD.

• 07290114350006 - NovApex: 2024-01-01NovApex N-31 Apex Locator
• 07290114350006 - NovApex: 2024-01-01 NovApex N-31 Apex Locator
• 07290114351003 - Bingo-Pro: 2024-01-01 Bingo-Pro Apex Locator
• 07290114351102 - Canal-Pro: 2024-01-01 Canal-Pro Apex Locator
• 07290114353007 - RomiApex: 2024-01-01 RomiApex A-15 Apex Locator
• 07290114353205 - Detect: 2024-01-01 Detect Apex Locator
• 07290114354004 - Wirelex: 2024-01-01 Wirele-X Apex Locator
• 07290114359009 - Endo-Eze Find: 2024-01-01 Endo-Eze Find Apex Locator