OneArch Scan Body KIT

GUDID 08800342289710

Osstem Implant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08800342289710
• NIH Device Record Key: c2242cac-4baa-48a1-8ae7-fa24426ffb14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneArch Scan Body KIT
• Version Model Number: OASBK
• 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: true
• 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	08800342289710 [Primary]

FDA Product Code

• NYE: Fixture Mount Kit

Sterilization

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

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

[08800342289710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-13
• Device Publish Date: 2026-03-05

Devices Manufactured by Osstem Implant Co., Ltd.

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• 08800000987316 - Bone Screw, Bone Tack: 2026-03-17
• 08800000987323 - Bone Screw, Bone Tack: 2026-03-17
• 08800000987330 - Bone Screw, Bone Tack: 2026-03-17
• 08800000987347 - Bone Screw, Bone Tack: 2026-03-17
• 08800000987354 - Bone Screw, Bone Tack: 2026-03-17
• 08800000987361 - Bone Screw, Bone Tack: 2026-03-17