TL MINI KIT

GUDID 06947600302094

BIO CONCEPT Co., Ltd.

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

• Primary Device ID: 06947600302094
• NIH Device Record Key: 88cac8fe-f316-4d6c-bf39-98e479687ffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TL MINI KIT
• Version Model Number: 056500
• Company DUNS: 527603266
• Company Name: BIO CONCEPT 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: false
• 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	06947600302094 [Primary]

FDA Product Code

• NYE: Fixture Mount Kit

Sterilization

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

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

[06947600302094]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-02
• Device Publish Date: 2025-03-25

Devices Manufactured by BIO CONCEPT Co., Ltd.

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• 06936616987746 - Dome Drill,Φ7.0mm, L25mm: 2025-04-02
• 06936616987753 - Dome Drill,Φ7.0mm, L26mm: 2025-04-02
• 06936616987760 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L31mm: 2025-04-02
• 06936616987777 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L37mm: 2025-04-02
• 06936616987784 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L31mm: 2025-04-02
• 06936616987791 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L37mm: 2025-04-02
• 06936616987807 - Osteotome maxillary sinus elevation Drill,Φ3.3mm, L31mm: 2025-04-02