Wirelex

GUDID 07290114354004

Wirele-X Apex Locator

FORUM ENGINEERING TECHNOLOGIES (96) LTD.

Endodontic apex locator

• Primary Device ID: 07290114354004
• NIH Device Record Key: 1f6425e5-22f2-4566-ad31-01edc39e5e39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wirelex
• Version Model Number: W-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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290114354004 [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

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

Moist Heat or Steam Sterilization

[07290114354004]

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.

• 07290114352000 - Spotter Device (without accessories): 2024-09-26 Spotter Device (without accessories)
• 17290114352007 - Spotter Device Set: 2024-09-26 Spotter Device set
• 17290114352106 - Spotter Demo set: 2024-09-26 Spotter Demo set
• 17290114352205 - Spotter Probes - Package of 2: 2024-09-26 Spotter Probes - Package of 2
• 17290114352304 - Spotter Sensors - Package of 5: 2024-09-26 Spotter Sensors - Package of 5
• 17290114352908 - Sensors: 2024-09-26 Sensors
• 07290114350006 - NovApex: 2024-01-01 NovApex N-31 Apex Locator
• 07290114351003 - Bingo-Pro: 2024-01-01 Bingo-Pro Apex Locator