EQ-PEX

GUDID 08809455601167

META SYSTEMS CO., LTD.

Endodontic apex locator

Primary Device ID	08809455601167
NIH Device Record Key	5c92628f-bd49-4722-96a9-bda6542ff426
Commercial Distribution Status	In Commercial Distribution
Brand Name	EQ-PEX
Version Model Number	P2901
Company DUNS	687503532
Company Name	META SYSTEMS CO., LTD.
Device Count	1
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	false
Manufacturing Date	false
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	08809455601167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210789

FDA Product Code

LQY	Locator, Root Apex

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

[08809455601167]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-18
Device Publish Date	2022-01-10

Devices Manufactured by META SYSTEMS CO., LTD.

08809455601723 - Elements Gutta Percha Cartridge 10 PCS	2025-01-07 The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gutta-percha material. It is used
08809455601730 - Elements Gutta Percha Cartridge 10 PCS	2025-01-07 The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gutta-percha material. It is used
08809455601747 - Elements Gutta Percha Cartridge 10 PCS	2025-01-07 The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gutta-percha material. It is used
08809455602072 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
08809455602089 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
08809455602096 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
08809455602102 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.
08809455602119 - Apex ID	2025-01-07 Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.

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