OneGuide KS Implant Driver

GUDID 08809917098719

Osstem Implant Co., Ltd.

Surgical screwdriver, reusable

• Primary Device ID: 08809917098719
• NIH Device Record Key: 4b228bf5-f2de-4c7c-be76-4d0da0bb4ceb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneGuide KS Implant Driver
• Version Model Number: OGFDR57K
• 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	08809917098719 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

Moist Heat or Steam Sterilization

[08809917098719]

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 KS Implant Driver]

• 08809917098719: OGFDR57K
• 08809917098702: OGFDR50K
• 08809917098696: OGFDM50K
• 08809917098689: OGFDM35K
• 08800271234003: HOGIDHSR57K
• 08800271234225: OGIDHSR57K
• 08800271249670: HOGFDRH57K
• 08800271249656: HOGFDRH50K
• 08800271249632: HOGFDMH50K