Mallet

GUDID 08800041038121

Surgident Co.,Ltd.

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• Primary Device ID: 08800041038121
• NIH Device Record Key: 1b839166-cf64-4948-8549-758f8deb8704
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mallet
• Version Model Number: MT-414
• Company DUNS: 689846448
• Company Name: Surgident Co.,Ltd.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	08800041038121 [Primary]

FDA Product Code

• ECT: Driver, Band, Orthodontic

Sterilization

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

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

[08800041038121]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-26
• Device Publish Date: 2023-10-18

Devices Manufactured by Surgident Co.,Ltd.

• 08800041065691 - Easy Bone Expander Kit: 2023-11-02
• 08800041065714 - P.R.P MEMBRANE KIT: 2023-11-02
• 08800041065721 - POWERTOME KIT: 2023-11-02
• 08800041065738 - Implant Removal Kit Gen II: 2023-11-02
• 08800041065745 - Screw Fixation Kit: 2023-11-02
• 08800041065752 - Drill Stop Kit: 2023-11-02
• 08800041065769 - Shatkin F.I.R.S.T Sinus Lift Kit: 2023-11-02
• 08800041065776 - Contra Torque: 2023-11-02