OneGuide TS Implant Driver

GUDID 08800271233983

Osstem Implant Co., Ltd.

Surgical screwdriver, reusable

• Primary Device ID: 08800271233983
• NIH Device Record Key: ba5c1c65-2a39-42b9-bd1c-929a61f87197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneGuide TS Implant Driver
• Version Model Number: HOGIDHSM57
• 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	08800271233983 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08800271233983]

Moist Heat or Steam Sterilization

[08800271233983]

Moist Heat or Steam Sterilization

[08800271233983]

Moist Heat or Steam Sterilization

[08800271233983]

Moist Heat or Steam Sterilization

[08800271233983]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [OneGuide TS Implant Driver]

• 08809917109170: OGFDR57
• 08809917109163: OGFDR50
• 08809917109125: OGFDM50
• 08800271233990: HOGIDHSR57
• 08800271233983: HOGIDHSM57