Optimus

GUDID 08800071018964

OSTEONIC CO.,Ltd.

Fluted surgical drill bit, reusable

• Primary Device ID: 08800071018964
• NIH Device Record Key: 728633ad-63e2-4af7-b92b-c8aea135221c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimus
• Version Model Number: NDB-02
• Company DUNS: 688999370
• Company Name: OSTEONIC 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: 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	08800071018964 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[08800071018964]

Moist Heat or Steam Sterilization

[08800071018964]

Moist Heat or Steam Sterilization

[08800071018964]

Moist Heat or Steam Sterilization

[08800071018964]

Moist Heat or Steam Sterilization

[08800071018964]

Moist Heat or Steam Sterilization

[08800071018964]

Moist Heat or Steam Sterilization

[08800071018964]

Moist Heat or Steam Sterilization

[08800071018964]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-12
• Device Publish Date: 2025-06-04

Devices Manufactured by OSTEONIC CO.,Ltd.

• 08800071018964 - Optimus: 2025-06-12
• 08800071018964 - Optimus: 2025-06-12
• 08800298539143 - GENIE PEEK/Bio Knotless Anchor: 2025-02-14 3.75mm Bio PEEK anchor
• 08800298539150 - GENIE PEEK/Bio Knotless Anchor: 2025-02-14 4.75mm Bio PEEK anchor
• 08800298539167 - GENIE PEEK/Bio Knotless Anchor: 2025-02-14 5.5mm Bio PEEK anchor
• 08800298539174 - GENIE PEEK/Bio Knotless Anchor: 2025-02-14 6.5mm Bio PEEK anchor
• 08800298539181 - GENIE PEEK Knotless Anchor: 2025-02-14 3.75mm PEEK anchor
• 08800298539198 - GENIE PEEK Knotless Anchor: 2025-02-14 4.75mm PEEK anchor
• 08800298539204 - GENIE PEEK Knotless Anchor: 2025-02-14 5.5mm PEEK anchor