File Hook(1pcs)

GUDID 08800025400524

Accessories of Apex Locator

GOOD DOCTORS CO., LTD.

Endodontic apex locator

• Primary Device ID: 08800025400524
• NIH Device Record Key: 8497d9f5-7f76-407f-b559-befa1ea51024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: File Hook(1pcs)
• Version Model Number: AC0401
• Company DUNS: 688201036
• Company Name: GOOD DOCTORS 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800025400524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151274

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

[08800025400524]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-31
• Device Publish Date: 2023-08-23

Devices Manufactured by GOOD DOCTORS CO., LTD.

• 08800025400456 - Dr's Light PRIME: 2023-09-01 ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• 08800025400463 - Dr's Light CHOICE: 2023-09-01 ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• 08800025400524 - File Hook(1pcs): 2023-08-31Accessories of Apex Locator
• 08800025400524 - File Hook(1pcs): 2023-08-31 Accessories of Apex Locator
• 08800025400531 - Lip Hook(3pccs): 2023-08-31 Accessories of Apex Locator
• 18800025400156 - Dr.s cam V: 2020-01-24 Intraoral Camera
• 18800025400170 - EZ SHOT HD V: 2020-01-24 Intraoral Camera
• 18800025400019 - Whicam Story3_wireless: 2019-11-07 Intraoral camera
• 18800025400026 - Whicam Story3_wired: 2019-11-07 Intraoral camera