OneGuide Bone Profiler

GUDID 08800271234393

Osstem Implant Co., Ltd.

Paranasal sinus trephine

• Primary Device ID: 08800271234393
• NIH Device Record Key: 9ea2e500-1cf5-429b-b8a1-2ea99e599737
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneGuide Bone Profiler
• Version Model Number: OGBPSWC
• 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	08800271234393 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

[08800271234393]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

On-Brand Devices [OneGuide Bone Profiler]

• 08800271234195: HOGBPSWC
• 08800271234393: OGBPSWC