Surgical Instrument

GUDID 08800298539303

3.75mm Drill

OSTEONIC CO.,Ltd.

Fluted surgical drill bit, single-use

• Primary Device ID: 08800298539303
• NIH Device Record Key: 2bde1400-d9a9-4ed6-b6e9-b8f1b4a0a653
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Instrument
• Version Model Number: 375DRILL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08800298539303 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-14
• Device Publish Date: 2025-02-06

On-Brand Devices [Surgical Instrument]

• 08800298539334: 6.5mm Drill
• 08800298539327: 5.5mm Drill
• 08800298539310: 4.75 mm drill
• 08800298539303: 3.75mm Drill
• 08800298539297: 4.75 Bone Awl (Disposable)
• 08800298539280: 5.5 Bone Awl/Tap
• 08800298539273: 4.75 Bone Awl/Tap
• 08800298539266: 3.75 Bone Awl/Tap
• 08800298539259: 4.75mm Bone Awl
• 08800298539242: Guide