Removal Tool for Implant Mount

GUDID 08809917158444

Osstem Implant Co., Ltd.

Surgical screwdriver, reusable

• Primary Device ID: 08809917158444
• NIH Device Record Key: db78f139-4313-48aa-b69f-7d5ee109775d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Removal Tool for Implant Mount
• Version Model Number: HKRFR
• Company DUNS: 689051793
• Company Name: Osstem Implant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	08809917158444 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

[08809917158444]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

Devices Manufactured by Osstem Implant Co., Ltd.

• 08809917158444 - Removal Tool for Implant Mount: 2025-06-02
• 08809917158444 - Removal Tool for Implant Mount: 2025-06-02
• 08800271249595 - Flattening Drill: 2025-05-06
• 08800271249601 - Flattening Drill: 2025-05-06
• 08800271249618 - Flattening Drill: 2025-05-06
• 08800271249625 - OneGuide TS Implant Driver: 2025-05-06
• 08800271249632 - OneGuide KS Implant Driver: 2025-05-06
• 08800271249649 - OneGuide TS Implant Driver: 2025-05-06
• 08800271249656 - OneGuide KS Implant Driver: 2025-05-06