OneGuide Twist Drill

GUDID 08809917099143

Osstem Implant Co., Ltd.

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 08809917099143
• NIH Device Record Key: 4a05c930-014b-4ff4-befc-2f24e58b36e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneGuide Twist Drill
• Version Model Number: OGTD1506
• 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	08809917099143 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

[08809917099143]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-09
• Device Publish Date: 2023-11-01

On-Brand Devices [OneGuide Twist Drill]

• 08809917099242: OGTD2213T
• 08809917099228: OGTD2211T
• 08809917099204: OGTD2210T
• 08809917070227: HOGTD2213T
• 08809917070210: HOGTD2211T
• 08809917070203: HOGTD2210T
• 08809917099259: OGTD2213
• 08809917099235: OGTD2211
• 08809917099211: OGTD2210
• 08809917099198: OGTD2208
• 08809917099181: OGTD2208S
• 08809917099174: OGTD2207
• 08809917099167: OGTD2207S
• 08809917099150: OGTD1506W
• 08809917099143: OGTD1506
• 08800271234119: HOGTD2218WC
• 08800271234102: HOGTD2215WC
• 08800271234096: HOGTD2211WC
• 08800271234089: HOGTD2211WC
• 08800271234072: HOGTD2210WC
• 08800271234065: HOGTD2208SWC
• 08800271240592: OGTD2208SWC
• 08800271234294: OGTD2218WC
• 08800271234287: OGTD2215WC
• 08800271234270: OGTD2213WC
• 08800271234263: OGTD2211WC
• 08800271234256: OGTD2210WC