BV Standard KlT

GUDID 06947600319948

BIO CONCEPT Co., Ltd.

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

• Primary Device ID: 06947600319948
• NIH Device Record Key: 4b463bac-10d0-4c10-8321-cfdb0ce4dcc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BV Standard KlT
• Version Model Number: 357860
• 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	06947600319948 [Primary]

FDA Product Code

• NYE: Fixture Mount Kit

Sterilization

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

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

[06947600319948]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-05
• Device Publish Date: 2024-11-27

Devices Manufactured by BIO CONCEPT Co., Ltd.

• 06947600316695 - Drill Extender: 2024-12-05
• 06947600316909 - NoMount Torque Driver: 2024-12-05
• 06947600316916 - NoMount Torque Driver: 2024-12-05
• 06947600319948 - BV Standard KlT: 2024-12-05
• 06947600319948 - BV Standard KlT: 2024-12-05