Lip Hook(3pccs)

GUDID 08800025400531

Accessories of Apex Locator

GOOD DOCTORS CO., LTD.

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• Primary Device ID: 08800025400531
• NIH Device Record Key: 3484dc15-b9b5-4d5f-b138-09648e592b2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lip Hook(3pccs)
• Version Model Number: AC0407
• 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	08800025400531 [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

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

Moist Heat or Steam Sterilization

[08800025400531]

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

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• 08800025400531 - Lip Hook(3pccs): 2023-08-31 Accessories of Apex Locator
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• 18800025400026 - Whicam Story3_wired: 2019-11-07 Intraoral camera