AMII Implant Ratchet Driver

GUDID 08809986619884

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 08809986619884
• NIH Device Record Key: c5362b74-9930-4e01-a652-4210c49ccfef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMII Implant Ratchet Driver
• Version Model Number: MRMDS
• Company DUNS: 631169224
• Company Name: InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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	08809986619884 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

[08809986619884]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-15
• Device Publish Date: 2025-08-07

On-Brand Devices [AMII Implant Ratchet Driver]

• 08809986619952: MRMDNEL
• 08809986619945: MRMDNES
• 08809986619938: MRMDNL
• 08809986619921: MRMDNS
• 08809986619914: MRMDEL
• 08809986619907: MRMDES
• 08809986619891: MRMDL
• 08809986619884: MRMDS