SIMPLE KIT

GUDID 08800271225438

Osstem Implant Co., Ltd.

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

• Primary Device ID: 08800271225438
• NIH Device Record Key: f718a187-9ee3-45a0-a711-f7cc19f198dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLE KIT
• Version Model Number: HSMPK
• 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	08800271225438 [Primary]

FDA Product Code

• NYE: Fixture Mount Kit

Sterilization

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

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

[08800271225438]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-18
• Device Publish Date: 2024-09-10

Devices Manufactured by Osstem Implant Co., Ltd.

• 08800271260286 - 122 TAPER FULL KIT: 2025-09-15
• 08800271260293 - 122 TAPER KIT: 2025-09-15
• 08800271260309 - 485 KIT: 2025-09-15
• 08800271260316 - TAPER KIT: 2025-09-15
• 08809917162229 - OneGuide Taper Drill: 2025-08-01
• 08809917162243 - OneGuide Taper Drill: 2025-08-01
• 08809917162267 - OneGuide Taper Drill: 2025-08-01
• 08809917162274 - OneGuide Taper Drill: 2025-08-01